MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTICULAR SURFACE PROVISIONAL SZ 3 8MM; TEMPLATE

Model Number	00584102308
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka procedure, when the surgeon inserted the zuk size 3x8mm insert trial, it cracked internal to patient.The procedure was finished using a smith and nephew back up device, with no surgical delay and no injury to the patient.
Additional Manufacturer Narrative
The device, intended for used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is cracked and has signs of wear and tear from use., a review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.According to clinical/medical investigation, this case reports the trial insert broke inside the patient.Per email communication, the procedure was completed using a backup device, with no surgical delay and no injury to the patient.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.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 device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 3 8MM
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10433527
• Report Number: 1020279-2020-04094
• Device Sequence Number: 14018017
• Product Code: HWT
• UDI-Device Identifier: 00885556619445
• UDI-Public: 00885556619445
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 00584102308
• Device Catalogue Number: 00584102308
• Device Lot Number: 60204216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: Hospitalization; Required Intervention