MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 2 8MM; TEMPLATE

Model Number	00584102208
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, the poly locking tab broke, this occur inside the patient.The procedure was completed without delay.The surgery was completed with the same device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Updated d4: lot number y exp date and h4: manf date.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is chipped and contains burrs, rendering the device inoperative.The device shows signs of extensive use.The clinical/medical evaluation concluded that this case reports the poly locking tab broke while inside the patient.Per complaint details, the procedure was completed using the same device, with no surgical delay and no injury to the patient.It is unknown whether all pieces of the trial poly locking tab remained intact and/or were retrieved, as responses to the information requests were not received as of the time of this assessment.The patient impact beyond the reported event could not be determined.However, the procedure was reportedly completed without delay, using the same device, with no patient harm alleged; therefore, no further assessment is warranted at this time.Should clinically relevant documentation/information become available in the future, the medical assessment may be re-evaluated.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: ARTICULAR SURFACE PROVISIONAL SZ 2 8MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10262252
• Report Number: 1020279-2020-03133
• Device Sequence Number: 2865710
• Product Code: HWT
• UDI-Device Identifier: 00885556619384
• UDI-Public: 00885556619384
• 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,Followup
• Report Date (Section B): 08/09/2021

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: 00584102208
• Device Catalogue Number: 00584102208
• Device Lot Number: 62951736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/16/2020; 08/09/2021
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 08/28/2020; 08/09/2021
• 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