2.9MM GL HARD BONE DRILL
Report
- Report Number
- 3006108336-2021-00040
- Event Type
- Injury
- Date Received
- September 17, 2021
- Date of Event
- August 18, 2021
- Report Date
- October 20, 2022
- Manufacturer
- CAYENNE MEDICAL
- Product Code
- HTW
- UDI-DI
- 00887868270345
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 : PART# 912020 JUGGERKNOT DOUBLE LOADED LOT# 0002264389. PART# 912020 JUGGERKNOT DOUBLE LOADED LOT# P15466. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION CONFIRMS THAT THE DRILL BIT IS FRACTURED COMPLETELY AND THE FRACTURED PIECE WAS NOT RETURNED FOR EVALUATION. THE FRACTURE OCCURRED JUST AFTER THE BEGINNING OF THE DRILL FLUTES. THE REST OF THE DEVICE HAS COSMETIC SCRATCHES AND SLIGHT WEAR MARKS NEAR THE COLLAR. FRACTURE SURFACE ANALYSIS PERFORMED USING SEM ON THE HARD BONE DRILL SAMPLE SHOWED THAT IS SUSPECTED TO HAVE FRACTURED DUE TO REVERSE BENDING OVERLOAD. SEM MICROGRAPHS OF THE FRACTURE SURFACE SHOWED TWO POSSIBLE TWO CRACK INITIATION SITES DIAGONAL TO ONE-ANOTHER. SUSPECTED TWO CRACK INITIATION SITES IDENTIFIED AT TWO CORNERS OF THE SAMPLE SHOWED SIGNS OF SMEARING, LIKELY DUE TO POST FRACTURE DAMAGE. OVERLOAD MODE OF FRACTURE IDENTIFIED IN THE NON-SMEARED AREAS OF THE FRACTURE EXHIBITING DUCTILE DIMPLES. PREVIOUS ROOT CAUSE REMAINS UNCHANGED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. ROOT CAUSE ATTRIBUTED TO USE ERROR AS DEVICE WAS OPENED FROM ITS STERILE PACKAGING AND PLACED INTO LOANER KIT. AN ISSUE EVALUATION WAS CREATED TO LOOK FURTHER INTO THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
(B)(4). REPORT SOURCE: FOREIGN : (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, THE TIP OF THE JUGGERKNOT 2.9 DRILL BROKE AND THE TIP REMAINED IN THE PATIENT. THE JUGGERKNOT 2.9 ANCHOR WAS SUCCESSFULLY IMPLANTED, BUT THE PROCEDURE WAS SIGNIFICANTLY EXTENDED - APPROXIMATELY OVER 30 MINUTES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1384352 | 2.9MM GL HARD BONE DRILL | BIT, DRILL | HTW | CAYENNE MEDICAL | N/A | 71094-2 | 00887868270345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization| O | SEE H10.| UNKNOWN JUGGERKNOT 2.9.| UNKNOWN JUGGERKNOT 2.9 |