UNKN PEEK INTERFERENCE SCREW
Report
- Report Number
- 1219602-2023-00082
- Event Type
- Injury
- Date Received
- January 12, 2023
- Report Date
- September 30, 2025
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HWC
- PMA / PMN Number
- K080358
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INTERNAL COMPLAINT REFERENCE: (B)(4). PAPER: PMS-247 NEW ZEALAND ACL REGISTRY AD HOC REPORT FEB 2022. THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF THE PMS-247 NEW ZEALAND ACL REGISTRY AD HOC REPORT FEB 2022 FROM NEW ZEALAND THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.
INTERNAL REFERENCE NUMBER: (B)(4). B5 HAS BEEN UPDATED.
INTERNAL REFERENCE NUMBER: CASE-(B)(4). B5 HAS BEEN UPDATED.
IT WAS REPORTED THAT ON REGISTRY REVIEW PMS-247 NEW ZEALAND ACL REGISTRY AD HOC REPORT FEB 2022 , 1 PATIENT PRESENTED A CHONDRAL/MENISCAL PATHOLOGY AFTER AN ACL PROCEDURE USING A ULTRABUTTON AND BIOSURE SCREW DEVICES. THE PATIENT REQUIRED AN ADDITIONAL SURGERY CHRONDOPLASTY/MENISCECTOMY. PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT ON REGISTRY REVIEW PMS-247 NEW ZEALAND ACL REGISTRY AD HOC REPORT(B)(6) 2022 , 1 PATIENT PRESENTED A CHONDRAL/MENISCAL PATHOLOGY AFTER AN ACL PROCEDURE USING ONE (1) ULTRABUTTON AND BIOSURE SCREW DEVICES. THE PATIENT REQUIRED AN ADDITIONAL SURGERY CHRONDOPLASTY/MENISCECTOMY. PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT ON REGISTRY REVIEW PMS-247 (B)(6) ACL REGISTRY AD HOC REPORT (B)(6) 2022 , 1 PATIENT PRESENTED A CHONDRAL/MENISCAL PATHOLOGY AFTER AN ACL PROCEDURE USING A BIOSURE SCREW DEVICE. THE PATIENT REQUIRED AN ADDITIONAL SURGERY CHRONDOPLASTY/MENISCECTOMY. PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439226 | UNKN PEEK INTERFERENCE SCREW | SCREW, FIXATION, BONE | HWC | SMITH & NEPHEW, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention |