MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number	102453307
Medical Device Problem Codes	Difficult to Insert (1316); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 the surgery, the spacer was found to be deformed, and the unicompartmental tibial plateau did not match the spacer.Changed another two to continue the surgery, the same problem happened again.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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.H11 additional narrative: added: d9 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 = > deformed.It was reported that during the surgery, the spacer was found to be deformed, and the unicompartmental tibial plateau did not match the spacer.Changed another two to continue the surgery, the same problem happened again.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed deep scratches and deformations over the sigma hp uni ins sz3 7mm lm/rl surface.Additionally, device had signs of having been tried to implant.There is no indication that a design or manufacturing issue has caused the reported complaint condition.Deep scratches observed can be consistent with other tools and hard edges coming in contact with the device while attempting to implant the device.Furthermore, deformations observed can be traced to a component failure, as the scratches observed could have lead to this kind of damage; as well as unintended forces applied during the implantation procedure.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 evaluation was performed using the returned insert (sigma hp uni tib tray sz3 lmrl) as mating device.Functional test revealed that the devices could not assemble as intended due to the damage observed in the sigma hp uni ins sz3 7mm lm/rl.A manufacturing record evaluation was performed for the finished device m66w32 lot number, and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the sigma hp uni ins sz3 7mm lm/rl would have contributed to the complained device issue.¿ based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 = > a manufacturing record evaluation was performed for the finished device m66w32 lot number, and no non-conformances nor manufacturing irregularities were identified.Device history review = > a manufacturing record evaluation was performed for the finished device m66w32 lot number, and no non-conformances nor manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: SIGMA HP UNI INS SZ3 7MM LM/RL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21047615
• Report Number: 1818910-2024-26182
• Device Sequence Number: 8398516
• Product Code: NPJ
• UDI-Device Identifier: 10603295002536
• UDI-Public: (01)10603295002536(17)290531(10)M66W32
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K233980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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: 102453307
• Device Lot Number: M66W32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 03/03/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 01/07/2025; 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female