MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LARGE SLAP HAMMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71367553
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision surgery (competitor's devices) for a thr, the attachment from three large slap hammers to the trunnion of the stem gave way inside the patient while trying to extract a competitive femoral stem.There was no significant delay and the procedure was finished using the same device.Patient was not harmed.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Furthermore, it is not indicated for use with devices not manufactured by smith & nephew.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, 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: LARGE SLAP HAMMER
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11962810
• Report Number: 1020279-2021-05060
• Device Sequence Number: 3754691
• Product Code: JDG
• UDI-Device Identifier: 03596010403025
• UDI-Public: 03596010403025
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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 Expiration Date: 08/09/2011
• Device Model Number: 71367553
• Device Catalogue Number: 71367553
• Device Lot Number: 01GM01987
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 10/01/2021
• 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: Required Intervention