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

Model Number 00584102408

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 08/01/2020

Event Type  Injury  

Event Description

It was reported that during tka procedure the articular surface provisional sz 4 8mm cracked on the corner.This happened during use inside the patient.No delay.S&n back up device was available to complete the procedure.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.

Manufacturer Narrative

H10: additional information in d10.Results of investigation: 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 2016.A medical investigation was conducted and this case reports the corner of the trial insert cracked while inside the patient.Per complaint details, the procedure was completed using a backup device, with further complications.A photo of the device confirms the cracked corner.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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 risk management files found that the reported failure was documented appropriately.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.

• Brand Name: ARTICULAR SURFACE PROVISIONAL SZ 4 8MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10446453
• MDR Text Key: 204160137
• Report Number: 1020279-2020-04175
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00885556619506
• UDI-Public: 00885556619506
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00584102408
• Device Catalogue Number: 00584102408
• Device Lot Number: 63299216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention