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

Model Number 00584102408

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/11/2020

Event Type  Injury  

Event Description

It was reported that the insert trials broke while the instruments were inside the patient.No delay reported.No patient injuries reported.An s&n backup was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H6: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed and complaint could not be confirmed.The clinical investigation concluded that this case reports the trial insert broke inside the patient.Per complaint details, 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.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no 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 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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or 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 4 8MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10462759
• MDR Text Key: 204634697
• Report Number: 1020279-2020-04261
• 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,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention