MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC STEM TRIAL EXTRACT; EXTRACTION INSTRUMENTS

Catalog Number	865226
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instrument has an unknown allegation.The event did not happen during surgery.Additional event information: visual inspection of the returned sample found that tip of the device is broken off.Broken fragment was found stuck inside a pfc* flut tib rod trl 75 x 14.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that the instrument has an unknown allegation.The event did not happen during surgery.The product was returned to depuy synthes for evaluation.Visual inspection of the returned sample found that tip of the device is broken off.Broken fragment was found stuck inside the pfc* flut tib rod trl 75 x 14.The tip breakage is consistent with the user leveraging the extractor side to side while removing the rod trial from the patient bone resulting extractor tip breakage.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pfc stem trial extract would contribute to the device issue.Based on the investigation findings, the potential cause is traced to unintended use error, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PFC STEM TRIAL EXTRACT
• Common Device Name: EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19543479
• Report Number: 1818910-2024-12856
• Device Sequence Number: 18029979
• Product Code: HWB
• UDI-Device Identifier: 10603295216766
• UDI-Public: (01)10603295216766(10)TX6329
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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 Catalogue Number: 865226
• Device Lot Number: TX6329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown