MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED S-ROM*REAMER,TRIANG MILLER,SZ5; HIP INSTRUMENT/TRIAL

Catalog Number	540005
Medical Device Problem Codes	Bent (1059); Misconnection (1399)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	10/24/2017
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.
Event or Problem Description
It was reported that the srom miller shell is bent and t-handle frame no longer fits.It was also reported that it did not break into pieces and everything was retrieved.The surgery was not delayed.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary examination of the returned instrument confirmed the complaint.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 will be filed as appropriate.
Event or Problem Description
Complaint description: it was reported that the srom miller shell is bent and t-handle frame no longer fits.It was also reported that it did not break into pieces and everything was retrieved.The surgery was not delayed.

• Common Device Name: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey IN 46582
• MDR Report Key: 7050314
• Report Number: 1818910-2017-29592
• Device Sequence Number: 1260045
• Product Code: HSD
• UDI-Device Identifier: 10603295173540
• UDI-Public: 10603295173540
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K080990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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: 540005
• Device Lot Number: VG0793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1