MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI ANTERIOR CHISEL; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Catalog Number	202485000
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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.E1 initial reporter facility address: (b)(6).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 osteotome was bent, therefore it does not fit through the jig.The case proceeded, but caused the item to become damaged.There was no patient consequence.The surgery was prolonged by two minutes due to the event.The chisel was broken during surgery.
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.H11 additional narrative: added: d9.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 osteotome is bent, therefore it does not fit through the jig.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the tip was broken.The broken fragment was returned stuck in 202471500 sigma hp uni fem fin blk sz 5.Additionally, the let surface was deformed.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.A functional test was not conducted due to post manufacturing damage.However, based on the observed condition of the device it is not unreasonable to conclude the device experienced difficulty to assemble, resulting in the subsequent breakage of the tip.A dimensional inspection was not conducted due to not being applicable to the complaint condition the overall complaint was confirmed as the observed condition of the sigma hp uni anterior chisel would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use, 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 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 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 records evaluation (mre) was not performed.
Additional Manufacturer Narrative
The device malfunction, device interaction (2+ devices) : unable to assemble, 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.
Additional Manufacturer Narrative
The device malfunction, visual : deformed/bent, 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: SIGMA HP UNI ANTERIOR CHISEL
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 20353404
• Report Number: 1818910-2024-20621
• Device Sequence Number: 6480020
• Product Code: FZO
• UDI-Device Identifier: 10603295084020
• UDI-Public: (01)10603295084020(10)PG334237
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,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: 202485000
• Device Lot Number: PG334237
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 11/28/2024; 08/20/2025; 08/20/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/05/2024; 11/29/2024; 08/20/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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