MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC REV/RT/RT MOD. SLAP HAMMER; MALLET

Model Number	75100394
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection the rod on the slap hammer was noticed bent and the hammer doesn't slide.No case involved.
Additional Manufacturer Narrative
H3, h6: it was reported that during inspection, the rod of the slap hammer was noticed bent and the hammer does not slide.No case was involved.The device is a third party device and the complaint device, intended for use in treatment, was returned for investigation.The part was sent to the legal manufacturer mps précimed for investigation.Mps confirmed the reported issue upon visual inspection, it is confirmed the mass of the slap hammer cannot slide along the rod.There are significant signs of use such as scratches and deep indentations.The observed damage does not conform to the intended use.The production documentation were reviewed, no deviations from the standard manufacturing procedure were found which could have contributed to the reported issue.The material and hardness certificate were conforming to the specifications.The complaint history review was performed, 3 further complaints were found for the part with the same defect.The risk management review was performed, the severity and the failure mode are covered through the risk management.Based on the conducted investigation, the root cause could be attributed to off-label use.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.No further actions are deemed necessary.Mps précimed will continue to monitor for trends.Smith+nephew will continue to monitor for similar issues for third party devices.The complaint device was sent to the legal manufacturer of the product.
Additional Manufacturer Narrative
This event should be re-evaluated for mdr reporting since smith & nephew is not the legal manufacturer of the device.The reassessment determined that the issue does not meet the threshold for us to reporting.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: TC REV/RT/RT MOD. SLAP HAMMER
• Common Device Name: MALLET
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11568219
• Report Number: 9613369-2021-00122
• Device Sequence Number: 3667274
• Product Code: HXL
• UDI-Device Identifier: 07611996117837
• UDI-Public: 07611996117837
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100394
• Device Catalogue Number: 75100394
• Device Lot Number: T14585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 06/04/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/26/2021; 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1