MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP PAC DISPOSABLE; ACCESSORIES,ARTHROSCOPIC

Model Number	7209874
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an arthroscopy using a disposable hip pac kit, one of the guide wire was placed over the cannula, after that the guide wire broke while the obrturator was being advanced so it was used another new guide wire from the same hip kit and it also broke.All the broken wires were successfully removed using tweezers.The procedure was completed using a back-up device.A delay greater than 30 minutes was reported.No other complications were reported.
Additional Manufacturer Narrative
The reported guidewires (2) from a disposable hip pac, used in treatment, have not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the guidewires broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the guidewires during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: HIP PAC DISPOSABLE
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10311999
• Report Number: 1219602-2020-01122
• Device Sequence Number: 19738815
• Product Code: NBH
• UDI-Device Identifier: 03596010529596
• UDI-Public: 03596010529596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 7209874
• Device Catalogue Number: 7209874
• Device Lot Number: 2042702
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR