MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ZT TRIAL SLEEVE 20D SML; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number	2576-20-110
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
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
Instruments damaged from previous srom cases.Found to be damaged at the case.X2 damaged sleeve trials need replacing -damaged.X1 11x16 stem trial needs replacing -damaged.X1 plastic frame sleeve needs replacing -is lost.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned, but a photo was provided confirming 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 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 manufacturing records evaluation (mre) was not performed.

• Brand Name: ZT TRIAL SLEEVE 20D SML
• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12356573
• Report Number: 1818910-2021-18446
• Device Sequence Number: 4115932
• Product Code: HWT
• UDI-Device Identifier: 10603295146759
• UDI-Public: 10603295146759
• 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): 08/23/2021

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: 2576-20-110
• Device Catalogue Number: 257620110
• Device Lot Number: MT41713
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1