MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM TAPER TAMP; RECLAIM INSTRUMENTS : TAMPS

Model Number	2975-00-675
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.Depuy-synthes 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.Re-opened-device received in on 12 feb 2020.Examination of the returned device confirmed the complaint.Functional testing was not possible as the bottom of the instrument was deformed.The root cause can be attributed to heavy usage and wear out.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
It was reported that the opening of tamp was too tight to fit over post.No pieces was noticed.No surgical delay.

• Brand Name: RECLAIM TAPER TAMP
• Common Device Name: RECLAIM INSTRUMENTS : TAMPS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9889077
• Report Number: 1818910-2020-09462
• Device Sequence Number: 2497563
• Product Code: HXG
• UDI-Device Identifier: 10603295156055
• UDI-Public: 10603295156055
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 11/25/2019

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 Model Number: 2975-00-675
• Device Catalogue Number: 297500675
• Device Lot Number: JD311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1