MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US THIN OSTEOTOME HANDLE; HIP INSTRUMENTS : HANDLES

Model Number	2422-10-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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
Compass case (b)(4) report: it was reported that while trying to remove the tibia with the flexible osteotome, the handle broke after multiple hits from the mallet.The screw that holds the osteotome on broke.This did not slow down the surgery and no parts were left in the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: he device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.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 review: 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: THIN OSTEOTOME HANDLE
• Common Device Name: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12476123
• Report Number: 1818910-2021-20195
• Device Sequence Number: 4081624
• Product Code: HWM
• UDI-Device Identifier: 10603295123071
• UDI-Public: 10603295123071
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 2422-10-000
• Device Catalogue Number: 242210000
• Device Lot Number: VZ13294
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR