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 Codes	Crack (1135); Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
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
Fracture collar instrument, color code shows cracks.
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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device was received.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: update 31-mar-2021: the investigation was re-opened upon receipt of the device.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 7914234
• Report Number: 1818910-2018-70687
• Device Sequence Number: 19417547
• Product Code: LXH
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/10/2018

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: 3480209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 11/13/2018; 03/17/2021; 04/05/2021
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/10/2018; 11/13/2018; 03/28/2021; 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1