MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE BOLT WRENCH; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71631140

Device Problem Separation Problem (4043)

Patient Problem No Information (3190)

Event Date 08/20/2018

Event Type  malfunction  

Event Description

It was reported that guide bolt wrench head snapped when trying to loosen guide bolt and detach the drill guide from the nail.Because of this issue a delay greater than 30 minutes was reported.

Manufacturer Narrative

The associated complaint device was not returned.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GUIDE BOLT WRENCH
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7870427
• MDR Text Key: 120100862
• Report Number: 1020279-2018-01764
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2015
• Device Catalogue Number: 71631140
• Device Lot Number: 05FM06221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1