MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*HANDLE SLEEVE DRIVER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	535801
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2018
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
New rep at (b)(6) medical center.During a case, the sleeve driver was disengaging from sleeve body used to impact the sleeve trial.The sleeve driver disengaged twice wile extracting the sleeve impactor body.This incident maybe added 20 seconds to the entire case.After the surgery, i examined the sleeve driver, and noticed the button which engages in the body was worn.Asking that this is replaced and shipped to: (b)(6).The damaged instrument will be returned to (b)(6).Lot code: ay0703.P.S: on the complaint tool; you are unable to add the lot code.The product won't add/upload when the lot is also typed patient consequence? no.
Additional Manufacturer Narrative
(b)(4).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, a follow-up medwatch will be filed as appropriate.

• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7554206
• Report Number: 1818910-2018-60890
• Device Sequence Number: 177639
• Product Code: HWR
• UDI-Device Identifier: 10603295172710
• UDI-Public: 10603295172710
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 535801
• Device Lot Number: AY0703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 05/30/2018
• 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