MAUDE Adverse Event Report: DEPUY IRELAND 9616671 S-ROM*SHAFT PILOT 18X13; HIP INSTRUMENT

Catalog Number	534153
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
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
Procedure: total hip replacement.During the procedure, the s-rom triangle miller handle was broken by the surgeon during attempts to remove a miller shell and shaft pilot that had become "stuck" inside the femoral canal.It is unclear as to why the miller shell and shaft pilot had become stuck, but a small femoral fracture occurred whilst attempting to remove the "stuck" instruments.This was rectified intra-operatively by the surgeon by placing a cerclage cable around proximal portion of the fractured femur.Female patient id (b)(6), initials (b)(6).Action taken: a slap hammer extraction device was used to remove the "stuck" instruments, following which the case was completed.It was also noted damage to one of the 20x15 s-rom shaft pilots (reported above) included in this kit, but it is unclear as to when or how that damage occurred?.
Additional Manufacturer Narrative
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 device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7065947
• Report Number: 1818910-2017-50365
• Device Sequence Number: 16618379
• Product Code: LXH
• UDI-Device Identifier: 10603295171751
• UDI-Public: 10603295171751
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 534153
• Device Lot Number: V0796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 04/18/2018; 10/23/2018
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 04/20/2018; 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention