ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE
Report
- Report Number
- 1219602-2025-02090
- Event Type
- Malfunction
- Date Received
- August 26, 2025
- Date of Event
- July 28, 2025
- Report Date
- September 30, 2025
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H11: INTERNAL COMPLAINT REFERENCE (B)(4). H2: ADDITIONAL INFORMATION: H6: MEDICAL DEVICE PROBLEM CODE. H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THE DEVICE WAS RETURNED IN ORIGINAL PACKAGING WITH THE BATCH NUMBER OF THE COMPLAINT ON THE LABEL. THE SUTURE SHUTTLE AND FOUR DEFORMED MONOFILAMENTS WERE RETURNED. THE SUTURE SHUTTLE HAS NO VISIBLE DEFECTS. A FUNCTIONAL EVALUATION USING THE RETURNED MONOFILAMENTS IN THE SUTURE SHUTTLE SHOWED THAT IT WILL ADVANCE THE MONOFILAMENTS FOLDED FOR A LOOP, FOR BOTH FREE ENDS, AND FOR A SINGLE FREE END AS INTENDED. AN IMAGE EVALUATION WAS PERFORMED AND FOUND WHAT SEEMS TO BE A BLACK NYLON MONOFILAMENT IS BEING HELD, IT CAN BE APPRECIATED THAT IT IS DIVIDED IN TWO. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE PROCEDURAL VARIANCE, OR DEVIATIONS FROM ESTABLISHED PROTOCOLS, INCREASING RISKS AND LEADING TO UNINTENDED CONSEQUENCES (EXCESSIVE FORCE OR CONTACT WITH A SHARP SOURCE). BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
INTERNAL REFERENCE NUMBER: (B)(4). H3,H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR 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 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 INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.
B5,D1,D4,H4,H6 HAVE BEEN UPDATED.
IT WAS REPORTED THAT, DURING A RIGHT SHOULDER INJURY REPAIR, THE ACCU-PASS BROKE WHEN THE DOCTOR WAS PULLING OUT THE THREAD. SURGERY WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT, DURING A RIGHT SHOULDER INJURY REPAIR, THE ACCU-PASS BROKE WHEN THE DOCTOR WAS PULLING OUT THE THREAD. THE BROKEN PIECES WERE REMOVED USING TWEEZERS. SURGERY WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE, USING STEEL WIRE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2779632 | ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | SMITH & NEPHEW, INC. | 2149771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Male |