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

Model Number	71430829
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during knee revision surgery of a primary triathlon tkr to a legion revision tkr, a genesis ii articular insert spacer trial size 5-6 13mm was not firmly attaching to the genesis ii posterior stabilizing articular trial size 5-6 9mm.On closer inspection, it was observed that the genesis ii posterior stabilizing articular trial size 5-6 9mm seemed to have cracks in the white ¿o rings¿ that are inset into the holes that the genesis ii articular insert spacer trial size 5-6 13mm clicks into.The insert spacer does not appear to have any damage.Surgery was resumed, without any delay, with a smith & nephew back-up constrained insert.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Results of investigation: the device was not returned for evaluation but the pictures were reviewed, and the cracked device was confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.The contribution of the device to the reported event could be corroborated, since the device was cracked, therefore it could be used correctly anymore.Based on this investigation, the need for corrective action is not indicated.Should the device or 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 SZ5-6 9MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13935404
• Report Number: 1020279-2022-01381
• Device Sequence Number: 11765545
• Product Code: LXH
• UDI-Device Identifier: 03596010213495
• UDI-Public: 03596010213495
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: 71430829
• Device Catalogue Number: 71430829
• Device Lot Number: 11EM12125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420026, GNS II FEM SIZE 6 RIGHT, LOT: 13DM14901; 71420190, GNS II TIB SZ 7 RIGHT, LOT: 13GT32378; 71420632, GII LNG STEM 14MM X 100MM, LOT:10EM09392; 71420652, GII LNG STEM 18MM X 150MM,LOT:11KSM0008A; G2 INS SPAC TR SZ5-6 13MM
• Patient Sex: Unknown