MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE BODY SZ 14 -5 TR; EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS

Model Number	2100-50-000
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device found damage to the color marking.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 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
Stc complained they thought the instrument was a defective in the green area.They will not use this one because of the defect.

• Brand Name: GLOBAL UNITE BODY SZ 14 -5 TR
• Common Device Name: EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11588650
• Report Number: 1818910-2021-06419
• Device Sequence Number: 4767005
• Product Code: HWT
• UDI-Device Identifier: 10603295085775
• UDI-Public: 10603295085775
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 02/10/2021

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: 2100-50-000
• Device Catalogue Number: 210050000
• Device Lot Number: 9169835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1