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

Model Number	2024-46-010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
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 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 instrument locking cap was broken off one end.
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 - instrument locking cap has broken off one end (lot gm0808 not validated ) please refer to image the product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.The device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device found the end cap component fractured at the center of the pin that secures the cap to the shaft, the pin was not returned.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The sigma unicondylar surgical technique guide (dsus/jrc/1114/0582) states "use the tibial osteotome to gently remove the bone from the keel slot.Do not impact forcefully as this can cause a break of the posterior tibia".A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to complaint condition.The overall complaint was confirmed as the observed condition of the sigma hp uni ap keel osteotome would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error, 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 - a date code was provided, which indicates that the device was manufactured on ((b)(6) 2008).A manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.Corrected h3.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device was not returned to depuy synthes for evaluation.However, photo(s) were provided for review.Review of the provided photo(s) confirms, that locking cap of instrument has broken.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible, because the date code provided is not a finished goods lot number.

• Brand Name: SIGMA HP UNI AP 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17183888
• Report Number: 1818910-2023-12796
• Device Sequence Number: 6809212
• Product Code: HWM
• UDI-Device Identifier: 10603295083160
• UDI-Public: 10603295083160
• 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): 06/22/2023

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: 2024-46-010
• Device Catalogue Number: 202446010
• Device Lot Number: GM0808
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 08/17/2023; 08/21/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/20/2023; 08/18/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2008
• 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