MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 DISH ART TR SZ5-6 11MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71430780
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while inside the patient, the genesis ii dished articular insert trial size 5-6 11mm cracked.Procedure concluded with the same device.It is unknown if a delay occurred due to this event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the device cracked during the procedure; however, the case concluded with the same device and no patient injury was reported.Responses to the documentation/information requests were not provided.Based on the information provided, the root cause could not be definitively concluded.No further patient impact is anticipated as the procedure reportedly was completed using the same device and no patient injury was alleged.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 did not reveal additional complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable, damage may occur 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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 DISH ART TR SZ5-6 11MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10942657
• Report Number: 1020279-2020-06954
• Device Sequence Number: 14158117
• Product Code: LXH
• UDI-Device Identifier: 03596010213235
• UDI-Public: 03596010213235
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/02/2021

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: 71430780
• Device Catalogue Number: 71430780
• Device Lot Number: 10JM19540
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 09/02/2021
• 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