MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 4 8MM; TEMPLATE

Model Number	00584102408
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during procedure the poly trial cracked when trying to take it out of the patient.This was a journey (femur) / zuk (tibia) unicompartmental knee.There was a delay less than or equal to 30 minutes.The procedure was finished using a smith and nephew back up device.No injury reported.
Additional Manufacturer Narrative
Investigation results: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirms a piece of the corner of the device broke off.Both pieces were returned for evaluation.The device shows extreme signs of wear/usage.The device was manufactured in 2011.A medical investigation was conducted and this case reports that the trial cracked in half while trialing the implants.Per complaint details, the procedure was completed with no harm to the patient with minimal delay, using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 the risk management file revealed this failure mode was previously identified.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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: ARTICULAR SURFACE PROVISIONAL SZ 4 8MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11417790
• Report Number: 1020279-2021-01802
• Device Sequence Number: 3544739
• Product Code: HWT
• UDI-Device Identifier: 00885556619506
• UDI-Public: 00885556619506
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2021

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: 00584102408
• Device Catalogue Number: 00584102408
• Device Lot Number: 61906561
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/29/2021
• 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