MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 STD STRAIGHT STEM INSERT SHAFT; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	259807430
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
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
Depuy synthes loaner kit operator performed a functional testing of devices.During testing it was not possible to disassemble two instruments.No patient involvement.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STD STRAIGHT STEM INSERT SHAFT
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7595952
• Report Number: 1818910-2018-62020
• Device Sequence Number: 13753362
• Product Code: HWR
• UDI-Device Identifier: 10603295148401
• UDI-Public: 10603295148401
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NI
• 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
• Report Date (Section B): 05/18/2018

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: 259807430
• Device Lot Number: PG266741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1