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

Model Number	2011-03-029
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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 instruments were found broken in spd and worn out/stripped.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device identified the adapter mating end is stripped.The noted damage is consistent normal use and servicing and the investigation did not establish a need for corrective action.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.The complaint sample consisted of (1) 201103029 sig hp rev adp rem shaft long.Examination of the returned reamer shaft found wear on the flats where the connection feature at the end of the shaft attaches to the adapter.The damage/wear to the flats of the instrument is consistent with the reamer stripping at the connection point between the reamer and the fitted adapter after being subjected to hard cortical bone and heavy usage.The root cause is attributed to device wear from normal use and servicing.Based on this investigation's determination of device wear out as the root cause, no corrective action is being pursued.Complaint trends will be monitored by post market surveillance through sep-419.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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.Investigation summary: examination of the returned device identified the adapter mating end is stripped.The noted damage is consistent normal use and servicing and the investigation did not establish a need for corrective action.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device identified the adapter mating end is stripped.The noted damage is consistent normal use and servicing and the investigation did not establish a need for corrective action.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.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.
Additional Manufacturer Narrative
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: 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: 9901751
• Report Number: 1818910-2020-09688
• Device Sequence Number: 2497137
• Product Code: LXH
• UDI-Device Identifier: 10603295081487
• UDI-Public: 10603295081487
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup,Followup
• Report Date (Section B): 03/16/2020

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: 2011-03-029
• Device Catalogue Number: 201103029
• Device Lot Number: NB000608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 03/16/2020; 04/06/2020; 04/03/2020; 04/03/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/02/2020; 04/09/2020; 04/13/2020; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1