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

Model Number	71631140
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, while trying to take the guide bold out, additional force was applied to the driver and device broke while inside the patient.A delay greater than 30 minutes was reported and procedure concluded without injuries and with a back-up device from a competitor.The patient outcome is unknown.
Event or Problem Description
It was reported that during surgery, while trying to take the guide bold out, additional force was applied to the driver and device broke while inside the patient.All pieces were recovered and a delay greater than 30 minutes was reported.Procedure concluded without injuries and with a backup device from a competitor.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that this complaint from the united states reports that a guide bolt wrench broke while trying to remove the guide bolt in a procedure.All the pieces were recovered.A delay of greater than 30 minutes was reported.The procedure was concluded without injuries or harm to the patient, with a backup device from a competitor.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did reveal an additional complaint for the listed batch for the same failure mode.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 product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm 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: GUIDE BOLT WRENCH
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10292683
• Report Number: 1020279-2020-03316
• Device Sequence Number: 811141
• Product Code: HSB
• UDI-Device Identifier: 03596010419644
• UDI-Public: 03596010419644
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• 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,Followup,Followup,Followup
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631140
• Device Catalogue Number: 71631140
• Device Lot Number: 08HM14793
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 07/05/2021; 08/05/2021
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/11/2020; 07/08/2021; 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR