MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*STEM BODY TRIAL 22; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number	536322
Medical Device Problem Codes	Bent (1059); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
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.Went through instrument inventory on (b)(6) 2018, and noticed a few instruments that were in an unacceptable condition.This instrument was not used during a surgery and no staff member had mentioned the damage.This is a srom 22 proximal body (color: black).The groves where the neck trial sits are damaged ( bent, chipped).Asking that these are replaced and shipped to: (b)(6).The damaged instruments will be returned to (b)(4).Lot code: ss0199.On the complain tool; you are unable to add the lot code.The product won't add/upload when the lot is also typed.Patient consequence? no.Patient consequence description: not used in surgery.
Additional Manufacturer Narrative
Product complaint #: (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.

• Common Device Name: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7560316
• Report Number: 1818910-2018-61108
• Device Sequence Number: 2194137
• Product Code: LXH
• UDI-Device Identifier: 10603295172826
• UDI-Public: 10603295172826
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 536322
• Device Lot Number: SS0199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1