MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FIXATION BOLT WRENCH

Catalog Number	102911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery, wire fixation wrench edges have started to break away above the incision.No pieces fell into the wound and no injury.There was no delay.Procedure was concluded with a backup device from smith and nephew.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned fixation bolt wrench indicated some damage to the tabs, confirming the stated complaint.This device was manufactured in 2014, showing signs of wear from use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.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.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: FIXATION BOLT WRENCH
• Common Device Name: WRENCH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8643147
• Report Number: 1020279-2019-02043
• Device Sequence Number: 2011501
• Product Code: HXC
• UDI-Device Identifier: 03596010031839
• UDI-Public: 03596010031839
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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: 102911
• Device Lot Number: 14GTF0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/26/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1