MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LARGE SCREWDRIVER HANDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number 71173547

Device Problems Difficult to Remove (1528); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Event Description

It was reported that during inspection the driver was found to be stuck in handle.No case related.No injury, no backup needed.

Manufacturer Narrative

The devices, intended use in treatment, were returned for evaluation.A visual inspection confirmed the hexdriver is stuck in the screwdriver handle.The devices show significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.

• Brand Name: LARGE SCREWDRIVER HANDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10099822
• MDR Text Key: 193392703
• Report Number: 1020279-2020-01897
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 03596010519580
• UDI-Public: 3596010519580
• Combination Product (y/n): N
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 71173547
• Device Lot Number: 18LTM1146
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1