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

Catalog Number	202446010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the t5 rm/ll and lm/rl femur implants were missing.The tibial osteotome is used during the preparation of the tibial sigma base, i.E.At the end of the operation.Tibial osteoporosis all poly broke during the intervention.The intervention was able to take place normally.
Event or Problem Description
Additional information was received and stated: the tibial osteotome is used during the preparation of the tibial sigma base, i.E.At the end of the operation.There were no consequences for the patient.The rest of the intervention was able to take place normally.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : t5 rm/ll and lm/rl femur implants were missing.Tibial osteoporosis all polly broke during the intervention (photo attached).The intervention was able to take place normally.The product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo investigation revealed that sigma hp uni ap keel osteotome had the tip broken.The broken fragment its observed in the photo evidence provided.The allegation can be confirmed.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".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 ap keel osteotome would contribute to the complained device issue.Based on the investigation findings, 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 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 records evaluation (mre) was not performed.

• 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: 17860142
• Report Number: 1818910-2023-19946
• Device Sequence Number: 5930109
• Product Code: HWM
• UDI-Device Identifier: 10603295083160
• UDI-Public: 10603295083160
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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 Catalogue Number: 202446010
• Device Lot Number: GM3764701
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2013
• 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