MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEM FIN BLK SZ 4; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	202471400
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the punch that goes through cutting blocks gets stuck in two of the blocks.No pieces broke off, just gets stuck when you insert the punch in the cutting blocks.
Event or Problem Description
Additional information received: was there a surgical delay? if yes, what is the duration of the delay? no.Were there any adverse consequences that affected the patient because of the reported event? no.
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 which 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 is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported that the punch that goes through cutting blocks gets stuck in two of the blocks.No pieces broke off, just gets stuck when you insert the punch in the cutting blocks.The product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that sigma hp uni fem fin blk sz 4 has a little chipped under the cutting block due to contact with the chisel.However, the devices did not arrive jammed.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A functional test was performed with matting component returned cutting blocks and it is possible to assemble the chisel with difficulty.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the sigma hp uni fem fin blk sz 4 would not contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life, and 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 depuy synthes 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: 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: h3.

• Brand Name: SIGMA HP UNI FEM FIN BLK SZ 4
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• 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 ; 3035526892
• MDR Report Key: 19153353
• Report Number: 1818910-2024-08733
• Device Sequence Number: 8445514
• Product Code: HWT
• UDI-Device Identifier: 10603295083788
• UDI-Public: 10603295083788
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 04/22/2024

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: 202471400
• Device Lot Number: SO2033631
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 06/10/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/08/2024; 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2018
• 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 Age: 56 YR
• Patient Sex: Female