MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 BULLET TIP STEM INSERTER SHAFT; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	259807435
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2019
Type of Reportable Event	Serious Injury
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
It was reported that after impaction, the stem sat up proud and wouldn¿t fully seat.Stem extractors wouldn¿t thread into the implant to extract.Believed the bullet too inserter may have damaged the threads on impaction.There was a 30 minutes surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > examination of the returned bullet tip stem inserter did not confirm any product problem or contribution to the reported event.If additional information is received; it will be evaluated and processed per depuy procedures.  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.

• Brand Name: BULLET TIP STEM INSERTER 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: 8754278
• Report Number: 1818910-2019-97521
• Device Sequence Number: 2037992
• Product Code: HWR
• UDI-Device Identifier: 10603295148418
• UDI-Public: 10603295148418
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 259807435
• Device Lot Number: MT38577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/06/2019
• 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
• Patient Age: 52 YR