MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT RETAINING IMP. INSERTER; HIP INSTRUMENTS : IMPACTORS

Catalog Number 257005000

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976); Naturally Worn (2988)

Patient Problem Not Applicable (3189)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.

Event Description

Consignment instrument (corail stem inserter) was damaged by surgeon while trying to remove a half-inserted corail stem.Stem became 'stuck' 3-5mm higher than anticipated, surgeon removed the threaded shaft from the inserter, attached it to the stem, and began impacting the underside of the impaction plate to try to remove the stem.As a result the threads that connect the shaft to the sleeve are damaged and the instrument no longer assembles.No delay.Surgery was completed successfully.

Manufacturer Narrative

(b)(4).Investigation summary
=
> the device was reviewed by depuy engineering and confirmed the device has been worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.

• Brand Name: SUMMIT RETAINING IMP. INSERTER
• Type of Device: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8492405
• MDR Text Key: 141228536
• Report Number: 1818910-2019-90122
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295148548
• UDI-Public: 10603295148548
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 257005000
• Device Lot Number: A0608
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 03/31/2019; 06/12/2019
• Supplement Dates FDA Received: 04/09/2019; 06/12/2019
• Patient Sequence Number: 1