MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ3 9MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number	1024-53-309
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, the insert did not match the clasp and couldn't be clamped onto the tibial support.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos revealed not exhibited any defect and/or anomaly which could affect to the proper assembly of the device.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the returned device found witness marks that suggest there was the intent of implantation of the sigma hp uni ins sz3 9mm lm/rl however, there is no significant damage that could compromise the functionality of the device.Additionally, the mating component remains unknown and was not returned for investigation.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4); 2) date of manufacture: 03/26/2021; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: 02/28/2023; 5) ifu reference: 103085738 rev 2.Device history review: 1) quantity manufactured: (b)(4); 2) date of manufacture: 03/26/2021; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: 02/28/2023; 5) ifu reference: 103085738 rev 2.

• Brand Name: SIGMA HP UNI INS SZ3 9MM 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17164822
• Report Number: 1818910-2023-12572
• Device Sequence Number: 5744370
• Product Code: NPJ
• UDI-Device Identifier: 10603295002550
• UDI-Public: 10603295002550
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070267
• 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
• Report Date (Section B): 06/20/2023

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 Model Number: 1024-53-309
• Device Catalogue Number: 102453309
• Device Lot Number: JD0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 06/20/2023; 07/21/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 06/21/2023; 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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 Sex: Female
• Patient Weight: 67 KG