MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI FEMORAL INTRODUCR; KNEE INSTRUMENT : INSERTION DEVICES

Catalog Number	202456000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product broke in 2 parts during the impaction of the femur.For the other product: the screw of the bracelet broke in the screw thread.It was impossible to disassemble it for use.The impacted products were in contact with the patient.No patient consequence.Nothing to report regarding the actual state of the patient.The surgical technical had been changed: manual implantation, so less precise management of positioning and rotation.Surgical delay of 15 minutes.
Additional Manufacturer Narrative
Product complaint #: (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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the product broke in 2 parts during the impaction of the femur.For the other product: the screw of the bracelet broke in the screw thread.It was impossible to disassemble it for use.The impacted products were in contact with the patient.No patient consequence.Nothing to report regarding the actual state of the patient.The surgical technical had been changed: manual implantation, so less precise management of positioning and rotation.Surgical delay of 15 minutes.¿the product was not returned to depuy synthes, however photos were provided for review.See attachment [sigma 1].The photo investigation found that sigma hp uni femoral introducer was broken from the binding post, the broken fragment is not visible at the photos, however the reported allegation can be confirmed.A root cause for this condition cannot be determined.Since the device was not returned, a dimensional inspection cannot be performed.¿the overall complaint was confirmed as the observed condition of the sigma hp uni femoral introducer would contribute to the complained device issue.Based on the investigation findings, the potential cause is not established, 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP UNI FEMORAL INTRODUCR
• Common Device Name: KNEE INSTRUMENT : INSERTION 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 46581-0988 ; 3035526892
• MDR Report Key: 18749645
• Report Number: 1818910-2024-03855
• Device Sequence Number: 20410309
• Product Code: HWR
• UDI-Device Identifier: 10603295083290
• UDI-Public: 10603295083290
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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: 202456000
• Device Lot Number: GM3581002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 02/29/2024; 04/30/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/04/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2013
• 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