MAUDE Adverse Event Report: DEPUY IRELAND 9616671 SIG HP REV ADP REM SHAFT LONG; KNEE INSTRUMENT : REAMERS

Catalog Number	201103029
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.
Event or Problem Description
Sigma hp revision reamer shaft item 201103029 not functioning properly.Did not stay in hudson adapter.Delayed surgery for 10 minutes.Procedure completed successfully with other like instrument.No fragments generated.
Additional Manufacturer Narrative
(b)(4).Examination of the returned device revealed deformation and stripping.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.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: SIG HP REV ADP REM SHAFT LONG
• Common Device Name: KNEE INSTRUMENT : REAMERS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8374901
• Report Number: 1818910-2019-85927
• Device Sequence Number: 19326180
• Product Code: LXH
• UDI-Device Identifier: 10603295081487
• UDI-Public: 10603295081487
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 02/05/2019

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: 201103029
• Device Lot Number: NB16172R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/22/2019; 04/02/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/08/2019; 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1