MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SHORT V OSTEO 5MM X 7 3/4 IN; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Catalog Number	242108000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: 9/19/2023: lot so2040283 is invalid in ecm, jde and as400.Follow-up will be initiated to clarify lot of reported device.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 osteotome broke during cement extraction.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that osteotome broke during cement extraction.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that short v osteo 5mm x 7 3/4 in was found the tip broken, this can related of heavy usage and wear.Additionally corrosion on the metal flat.The allegation of broken can be confirmed.The broken fragment was not returned.Based on the investigation findings and taking into consideration the age of the device, a potential cause for this specific case is traced to end of life.The cracked condition compromised the integrity of the device along with the sterilization process and usage over the years contributed to the corrosion observed.Sterilization protocols were asked but not provided.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed for the short v osteo 5mm x 7 3/4 in was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the short v osteo 5mm x 7 3/4 in would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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: SHORT V OSTEO 5MM X 7 3/4 IN
• 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: 17834069
• Report Number: 1818910-2023-19652
• Device Sequence Number: 20555602
• Product Code: HWM
• UDI-Device Identifier: 10603295122784
• UDI-Public: 10603295122784
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 242108000
• Device Lot Number: SO2040283
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male