MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP POWER PIN DRIVER; KNEE INSTRUMENT : INSERTION DEVICES

Catalog Number	950502071
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the drill pins get jammed in the hp power pin guide and do not release the pin needs to be released, but it does not perform this function.There was five (5) minutes of surgical delay.The procedure was successfully completed.There was no patient consequence.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: drill pins jam in the hp power pin guide and do not release the pin when it is fixed in the bone.The pin must be released, which it does not do.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed the pin metal-housing stripped.Additionally, device had signs of usage and the mating component was not returned for evaluation.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 assembling the pin into the hole in an misaligned position.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage and as the mating component was not returned for evaluation.Therefore, with information provided, the reported allegation cannot be confirmed.A certificate of compliance was reviewed for the finished device so2058904 lot number, and no non-conformances nor manufacturing irregularities were identified.The overall complaint was not confirmed as the observed condition of the hp power pin driver would have not contributed to the complained 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.Device history lot: quantity manufactured: (b)(4).Date of manufacture: 12-oct-2022.Any anomalies or deviations identified in dhr: no.Expiry date: n/a.Ifu reference: ifu-0902-00-836.A certificate of compliance was reviewed for the finished device so2058904 lot number, and no non-conformances nor manufacturing irregularities were identified.Device history review: a certificate of compliance was reviewed for the finished device so2058904 lot number, and no non-conformances nor manufacturing irregularities were identified.

• Brand Name: HP POWER PIN DRIVER
• Common Device Name: KNEE INSTRUMENT : INSERTION DEVICES
• 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: 20685583
• Report Number: 1818910-2024-23786
• Device Sequence Number: 8557024
• Product Code: HWE
• UDI-Device Identifier: 10603295227878
• UDI-Public: (01)10603295227878(10)SO2058904
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 950502071
• Device Lot Number: SO2058904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 01/21/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/09/2024; 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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