MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 C/R ART TR SZ5-6 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71430500
Medical Device Problem Codes	Break (1069); Naturally Worn (2988)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the poly is chipped and worn.Fault in device was noticed during set up or inspection.Procedure was performed with a smith and nephew backup device.No delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the device has deep gouges/burrs, scratches and cracks in the plastic.The device shows extreme signs of wear/usage.The device was manufactured in 2004.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.The 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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.G1.

• Brand Name: G2 C/R ART TR SZ5-6 9MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10305353
• Report Number: 1020279-2020-03405
• Device Sequence Number: 754158
• Product Code: LXH
• UDI-Device Identifier: 03596010212139
• UDI-Public: 03596010212139
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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 Expiration Date: 10/29/2014
• Device Model Number: 71430500
• Device Catalogue Number: 71430500
• Device Lot Number: 04KM07056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1