MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 ENDURANCE STEM INSERTER; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	252100502
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	10/03/2018
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
The stem inserter tip got stuck to the attached part of the stem and it was not able to extract when the surgeon attempted to remove manually.
Additional Manufacturer Narrative
(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
Surgical delay 30 mins.
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: ENDURANCE STEM INSERTER
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7994700
• Report Number: 1818910-2018-73196
• Device Sequence Number: 289393
• Product Code: HWR
• UDI-Device Identifier: 10603295127796
• UDI-Public: 10603295127796
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 252100502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 11/08/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 10/31/2018; 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1