MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. INSERTION HANDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	00584305400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.Our assessment confirmed the insertion handle is stripped.The device shows significant signs of wear/usage.A review of complaint history for the part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/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.
Event or Problem Description
It was reported that device was found stripped during surgery.Surgery was completed without the usage of the device and there was no backup available.However, no patient injury was involved and there was no delay to the surgery.

• Brand Name: INSERTION HANDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7874407
• Report Number: 1020279-2018-01821
• Device Sequence Number: 2218286
• Product Code: MDM
• UDI-Device Identifier: 00885556621677
• UDI-Public: 00885556621677
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/13/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 00584305400
• Device Lot Number: 62656522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/13/2018
• 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