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

Model Number	71631140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while attempting to loosen the guide bold, during an intertan nail procedure, the tip of the guide bolt wrench broke off.A delay of more than 30 minutes reported.No additional patient injuries reported.An s&n backup was not available and the procedure had to be completed with a competitor device.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per subsequent e-mail, all the broken pieces were removed from inside of the patient.According to the report, the thirty-minute delay did not result in harm to the patient.However, since an s&n backup was not available, it was reported the procedure completed with a competitor device.Should additional medical information be provided, this complaint would be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode 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.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.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
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10566271
• Report Number: 1020279-2020-04777
• Device Sequence Number: 2562235
• Product Code: HSB
• UDI-Device Identifier: 03596010419644
• UDI-Public: 03596010419644
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71631140
• Device Catalogue Number: 71631140
• Device Lot Number: 14JM16491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 06/05/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 06/08/2021
• 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; Required Intervention