MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 32MM PINN AB IN TR 48; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number	2218-82-748
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2021
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
Pinnacle ab liner trial was damaged during case.Small metal locking ring broke and screw came away from plastic liner.It appears that all pieces were retrieved, but it is difficult to tell.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this report was not returned.However, a review of the provided photographs confirmed the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history review a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative:  h6 component code: appropriate term/code not available (g07002) used to capture measurement (g03).

• Brand Name: 32MM PINN AB IN TR 48
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11552568
• Report Number: 1818910-2021-05783
• Device Sequence Number: 4087480
• Product Code: HWT
• UDI-Device Identifier: 10603295101871
• UDI-Public: 10603295101871
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 2218-82-748
• Device Catalogue Number: 221882748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1