MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 HP EM TIBIAL JIG ANKLE CLAMP; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	950501229
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, 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 during loan kit inspection in it was noticed that the instrument was missing part 2 of 2.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "instrument missing part 2 of 2.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician." the product was not returned to medtech orthopedics, however photos were provided for review.See attachment '(b)(4).Jpg'.The photo investigation revealed that '950501229, hp em tibial jig ankle clamp' had fine assembly missing.Potential cause cannot be determined for missing components.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the hp em tibial jig ankle clamp would contribute to the complained device issue.Based on the investigation findings, cause not established 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 complaint condition.As part of medtech orthopedics 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 a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the j0908 (date code) provided is not a valid finished goods lot.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "instrument missing part 2 of 2.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician." the product was not returned to medtech orthopedics, however photos were provided for review.The photo investigation revealed that '950501229, hp em tibial jig ankle clamp' had fine assembly missing.Potential cause cannot be determined for missing components.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the hp em tibial jig ankle clamp would contribute to the complained device issue.Based on the investigation findings, cause not established 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 complaint condition.As part of medtech orthopedics 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: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the j0908 (date code) provided is not a valid finished goods lot.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
The device malfunction, visual: missing components, will no longer be reported as there has not been a serious injury associated with this failure within the past 2 years.Please consider this the last manufacturer report number submitted against this malfunction.

• Brand Name: HP EM TIBIAL JIG ANKLE CLAMP
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 21078045
• Report Number: 1818910-2025-00201
• Device Sequence Number: 12872761
• Product Code: HTZ
• UDI-Device Identifier: 10603295225348
• UDI-Public: (01)10603295225348(10)J0908
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,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: 950501229
• Device Lot Number: J0908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 02/10/2025; 08/19/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/09/2025; 02/11/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2008
• 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