MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT 58ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number	2218-32-058
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
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
Surgeon was removing a 58 gription sector cup because of an infection.Zimmer cup extractor was used with 32x58n liner trial.The outer edge of the liner was cut from the cup extractor blade.

• Brand Name: PIN TRL LNR NEUT 58ODX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10756223
• Report Number: 1818910-2020-23562
• Device Sequence Number: 3333973
• Product Code: LXH
• UDI-Device Identifier: 10603295100751
• UDI-Public: 10603295100751
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 10/15/2020

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: 2218-32-058
• Device Catalogue Number: 221832058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1