MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US STAND CUP TRIAL D38 +3MM; EXTREMITY INSTRUMENTS : HUMERAL TRIALS

Model Number	2307-38-403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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) reports: it was reported that the 38mm +3 poly trial split during trialing.All pieces were found and discarded.No surgical delay reported.
Event or Problem Description
Questions: a.What part of the instrument broke? b.Did it break into two or more pieces?" answers: hello.The plastic part broke and it broke down into 2 pieces.------------------------- it broke into 2 pieces.I don¿t remember which part.I think it just broke down the middle.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) investigation summary = > no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will bereviewed and the investigation will be re-opened as necessary.Device history lot = > a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.H10 additional narrative: added: b5.

• Brand Name: STAND CUP TRIAL D38 +3MM
• Common Device Name: EXTREMITY INSTRUMENTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12475888
• Report Number: 1818910-2021-20190
• Device Sequence Number: 16981737
• Product Code: HWT
• UDI-Device Identifier: 10603295115816
• UDI-Public: 10603295115816
• 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): 03/10/2021

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: 2307-38-403
• Device Catalogue Number: 230738403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1