MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII P/S ART TR SZ7-8 11MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71430846
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an office inspection it was found these insert trials very worn and chipped.No case involved.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned trial confirm the stated failure.The device has multiple scratches, burrs, and deep gouges in the plastic.There is a piece of the device missing.The piece was not returned for evaluation.There are no lot number for this device.This device exhibits signs of extreme use and wear.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: GII P/S ART TR SZ7-8 11MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10414391
• Report Number: 1020279-2020-03987
• Device Sequence Number: 19444413
• Product Code: LXH
• UDI-Device Identifier: 03596010213594
• UDI-Public: 03596010213594
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71430846
• Device Catalogue Number: 71430846
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1