MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM DIST REAMER EXTENSION; RECLAIM INSTRUMENTS : ADAPTORS

Catalog Number	297500500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
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
Distal reamer broke after use of surgery.Did the patient experience a post-op device malfunction? --> no, did the patient require revision surgery or hardware removal? --> no, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no.
Additional Manufacturer Narrative
B)(4).Investigation summary = > the device associated with this report was not returned.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: RECLAIM DIST REAMER EXTENSION
• Common Device Name: RECLAIM INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8583977
• Report Number: 1818910-2019-92637
• Device Sequence Number: 2359156
• Product Code: HTO
• UDI-Device Identifier: 10603295155911
• UDI-Public: 10603295155911
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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: 297500500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1