MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 P/S ART TR SZ3-4 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71430815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka, the genesis ii p/s art tr size 3-4 9mm broke inside the patient.The surgeon was using a poly inserter with a mallet while trying to put it in.There was no significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was broken into two pieces, rendering the device inoperative.The broken pieces was returned as well.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: G2 P/S ART TR SZ3-4 9MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11909995
• Report Number: 1020279-2021-04876
• Device Sequence Number: 17242068
• Product Code: LXH
• UDI-Device Identifier: 03596010213402
• UDI-Public: 03596010213402
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71430815
• Device Catalogue Number: 71430815
• Device Lot Number: 15BB02662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: Hospitalization; Other; Required Intervention
• Patient Weight: 141