MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FB KEEL OSTEOTOME; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Model Number	2024-47-111
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	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Surgeon prepared tibia with metal backed osteotome from sigma partial kit and the end cap fell off.No delay in surgery, tool still worked and surgeon successfully was able to complete the surgery.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary:examination of the returned device confirmed the reported breakage.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.
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
The device malfunction, functional : fell apart - unattached, 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 FB KEEL OSTEOTOME
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11225298
• Report Number: 1818910-2021-01774
• Device Sequence Number: 19725684
• Product Code: HWM
• UDI-Device Identifier: 10603295083191
• UDI-Public: 10603295083191
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 01/12/2021

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: 2024-47-111
• Device Catalogue Number: 202447111
• Device Lot Number: GM4214003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/10/2021; 03/23/2021; 08/22/2025
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/13/2021; 03/24/2021; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2014
• 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