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

Model Number	71430490
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tkr the size 3-4 (9mm) genesis ii cruciate retaining insert broke off when the surgeon was attempting to trial the knee.No pieces were left in the patient and no time added to the procedure.All the pieces were recovered and no surgical intervention needed.It was another insert in the room and used it in place of the damaged insert.No time was added to the procedure.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, this complaint reports the articular insert broke off when the surgeon was attempting to trial.Per email communication, no pieces were left in the patient and no time added to the procedure.All the pieces were recovered and no surgical intervention needed.Therefore, since no patient harm is being alleged, no further assessment is warranted at this time.A visual inspection confirmed the g2 c/r art tr sz3-4 9mm is broken in two pieces.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.

• Brand Name: G2 C/R 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: 10296218
• Report Number: 1020279-2020-03347
• Device Sequence Number: 11633967
• Product Code: LXH
• UDI-Device Identifier: 03596010212115
• UDI-Public: 03596010212115
• 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): 02/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71430490
• Device Catalogue Number: 71430490
• Device Lot Number: 11FM15224
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 02/09/2021
• 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: Required Intervention