MAUDE Adverse Event Report: DEPUY IRELAND 9616671 CELCON DARRAH RETRACTOR; EXTREMITY INSTRUMENTS : RETRACTORS

Catalog Number	223631000
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Operating room nurses were setting up for shoulder arthroplasty case when the wrapped darrach_d223631000 was opened it was noted there was a crack in the distal end of the instrument.Patient consequence? no.Action taken for procedure: another d223631000 was opened up for the case.
Additional Manufacturer Narrative
Investigation summary: review of the provided photographs confirm the reported event.The device associated with this report was not returned for evaluation.Depuy considers the investigation closed.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, a follow-up medwatch will be filed as appropriate. .

• Brand Name: CELCON DARRAH RETRACTOR
• Common Device Name: EXTREMITY INSTRUMENTS : RETRACTORS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7818469
• Report Number: 1818910-2018-67731
• Device Sequence Number: 16441131
• Product Code: GAD
• UDI-Device Identifier: 10603295106166
• UDI-Public: 10603295106166
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2018

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 Catalogue Number: 223631000
• Device Lot Number: BF0210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1