MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REVISION MODULAR STOP; ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES

Catalog Number	254600500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
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
It was reported that the instrument was found non-functional at the office.This modular stop (254600500) will not fit over any reamer that they had tried it on.They had tried multiple reamers 250620102 & 250620103 a total of 4 different sets of reamers.On reamers 250620102 the modular stop will pass over the initial part of the reamer however it will not continue into the modular stop path of the reamer.With reamer 250620103 the modular stop will start into the modular stop path but only half of the stop makes it into the channel, then it stops.They had tried flipping the modular stop around and the same it true with both sides.
Additional Manufacturer Narrative
(b)(4).Examination of the returned device confirms the reported event.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).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REVISION MODULAR STOP
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : DRILL GUIDES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8482701
• Report Number: 1818910-2019-89718
• Device Sequence Number: 19336619
• Product Code: LXH
• UDI-Device Identifier: 10603295478607
• UDI-Public: 10603295478607
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/21/2019

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: 254600500
• Device Lot Number: SO2029585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 05/08/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 04/25/2019; 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1