FAST-FIX 360 CURVED NDL DELIVERY SYS
Report
- Report Number
- 1219602-2022-00178
- Event Type
- Injury
- Date Received
- February 8, 2022
- Date of Event
- January 19, 2022
- Report Date
- June 16, 2023
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- GAT
- UDI-DI
- 00885554023077
- PMA / PMN Number
- K092508
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).
B5 WAS UPDATED. H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW OF THE PART DETERMINED THIS WAS A REPEAT EVENT. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE INSTRUCTIONS FOR USE, FAST FIX 360 WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.
INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).
H10: H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND THAT THE SUTURE AND BOTH ANCHORS WERE RETURNED DETACHED FROM THE DEVICE. THE DEPTH LIMITER BUTTON WAS IN THE DEFAULT POSITION. THE ACTUATOR TIP WAS IN THE T1 POSITION. A FUNCTIONAL EVALUATION REVEALED THAT THE ACTUATOR TIP FUNCTIONED AS DESIGNED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW OF THE PART DETERMINED THIS WAS A REPEAT EVENT. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE INADVERTENTLY BENDING OF THE NEEDLE/OVERMOLD ASSEMBLY. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.
IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THREE FAST-FIX HAD PROBLEMS (PN: 72202468, LOT NUMBERS: 2070814, 2075937 & 2080948), THE T1 CAME OUT VERY WELL, AT THE MOMENT OF TRY TO USE THE T2 , THIS ONE DID NOT COME OUT, THEY TRIED SEVERAL TIMES LOWERING THE GRAY PART IN ITS ENTIRETY AND THE SECOND PEEK NEVER WENT DOWN, SO IT WAS NECESSARY TO REMOVE THIS SUTURE FROM THE PATIENT, TWO OTHER SUTURES FROM DIFFERENT BATCHES WERE PASSED, WHICH FAILED IN THE SAME WAY. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THE T1 OF THE FAST-FIX CAME OUT VERY WELL, AT THE MOMENT OF TRYING TO DEPLOY T2, THIS ONE DID NOT COME OUT. THIS WAS TRIED SEVERAL TIMES LOWERING THE GRAY PART IN ITS ENTIRETY BUT THE SECOND PEEK NEVER WENT DOWN, SO IT WAS NECESSARY TO REMOVE THIS SUTURE FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT DURING USE IN AN ARTHROSCOPY, THREE FAST-FIX HAD PROBLEMS (PN: 72202468, LOT NUMBERS: 2070814, 2075937 & 2080948), THE T1 CAME OUT VERY WELL, AT THE MOMENT OF TRY TO USE THE T2 , THIS ONE DID NOT COME OUT, THEY TRIED SEVERAL TIMES LOWERING THE GRAY PART IN ITS ENTIRETY AND THE SECOND PEEK NEVER WENT DOWN, SO IT WAS NECESSARY TO REMOVE THIS SUTURE FROM THE PATIENT, TWO OTHER SUTURES FROM DIFFERENT BATCHES WERE PASSED, WHICH FAILED IN THE SAME WAY. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1849800 | FAST-FIX 360 CURVED NDL DELIVERY SYS | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | SMITH & NEPHEW, INC. | 72202468 | 2070814 | 00885554023077 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Other |