MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRIVER EXTRACTOR; EXTRACTION INSTRUMENTS

Catalog Number	204610000
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
Additional Manufacturer Narrative
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.Additional narrative: h3, h6: product investigation: the product returned to medtech orthopaedics for evaluation.The medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the overall surface of the device exhibits impactions marks and nicks.Additionally, the slide hammer handle component was missing.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces, such as, impaction forces applied to the device on not intended areas.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the driver extractor would have contribute to a device issue.Based on the investigation findings, 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 j&j medtech orthopaedics 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.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the following device was received as blind unit.However, it couldn't be associated with a complaint or any other existing record.As a result, this complaint was created to analyze the returned device.During manufacturer's investigation of the returned device it was identified that the overall surface of the device exhibits impactions marks and nicks.Additionally, the slide hammer handle component was missing.

• Brand Name: DRIVER EXTRACTOR
• Common Device Name: EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20651771
• Report Number: 1818910-2024-23418
• Device Sequence Number: 6697435
• Product Code: HWB
• UDI-Device Identifier: 10603295084365
• UDI-Public: (01)10603295084365(10)SO2056123
• Combination Product (Y/N): N
• 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

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: 204610000
• Device Lot Number: SO2056123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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