MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 5 10MM; TEMPLATE

Model Number	00584102510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the procedure, the poly trial cracked inside the patient when attempting to remove from the tibial trial.The procedure was completed without delay and backup from s+n was available to finish the surgery.No other complications were reported at this time.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported during the procedure, the poly trial cracked when attempting to remove from the tibial trial.Not any pieces fell inside the patient.The procedure was completed without delay and the backup from s+n was available to finish the surgery.No patient injury or other complications were reported.The patient did not present any problem and it is healthy.The surgeon was satisfied with the surgical outcome.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that during the procedure, the poly trial cracked while attempting to remove it from the tibial trial, however none of the pieces fell into the patient.Per email communication, the procedure was completed without any delay or patient injury, and a backup device was not necessary.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.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.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 repeated use can occur.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.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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 5 10MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10462936
• Report Number: 1020279-2020-04265
• Device Sequence Number: 2939674
• Product Code: HWT
• UDI-Device Identifier: 00885556619582
• UDI-Public: 00885556619582
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2021

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: 00584102510
• Device Catalogue Number: 00584102510
• Device Lot Number: 62710647
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020; 06/04/2021
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 08/31/2020; 06/07/2021
• 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