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

Model Number	102911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during procedure when tightening fixation bolt wrench, this broke.Instruments outside the patient.The procedure was completed without delay using a smith-nephew back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The visual inspection of the returned device confirms the stated failure that one of the tabs has a piece missing.The broken piece was not returned with the device.The device shows significant signs of wear/usage.A medical investigation was conducted and confirms per the complaint details, the fixation bolt wrench broke was outside of the patient.Based on the information provided, the procedure was completed without delay using a smith-nephew back-up device.Since there were no patient injuries or other complications were reported; no further clinical/medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FIXATION BOLT WRENCH
• Common Device Name: WRENCH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11548663
• Report Number: 1020279-2021-02316
• Device Sequence Number: 4047650
• Product Code: HXC
• UDI-Device Identifier: 03596010031839
• UDI-Public: 03596010031839
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 05/14/2021

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: 102911
• Device Catalogue Number: 102911
• Device Lot Number: 15KTF0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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; Other; Required Intervention