MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RET ROD AMBI/CL WRENCH; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71110024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a planned revision surgery for removal of an implant (from an unknown manufacturer), the tip of a ret rod ambi/cl wrench broke.The broken piece remained inside the mating part of the implant inside the patient.At the end, the implant was not explanted.It is unknown if there was any surgical delay.Patient was not harmed beyond the described event.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned ret rod ambi/cl wrench confirms the tip of the device is broken off.The broken piece was not returned with the device.This device shows signs of significant wear and use.A medical investigation was conducted and confirms the root cause of the reported wrench tip breakage could not be determined.The ret rod ammbi/cl wrenches are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.Since it was reported that broken piece was retained in the mating part in the implant, the possibility of micro-motion and/or migration, and local irritation/discomfort is unlikely.The impact to the patient beyond that which has been reported cannot be determined.No further medical assessment can be rendered 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 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.Expected wear/tear is likely the probable cause 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 complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: RET ROD AMBI/CL WRENCH
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11688989
• Report Number: 1020279-2021-03201
• Device Sequence Number: 14186952
• Product Code: KTT
• UDI-Device Identifier: 03596010173027
• UDI-Public: 03596010173027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 71110024
• Device Catalogue Number: 71110024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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