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

Catalog Number 257005100

Device Problems Connection Problem (2900); Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device was reviewed by depuy engineering (b)((4) which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being 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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeon reported to me directly during the case ((b)(6) hospital) that the corail stem inserter he used to implant the stem in the case had a worn/rounded off tip and therefore does not engage properly in the reciprocating hole in the top of the shoulder of the stem.This did not cause any issue this time but he reported has the potential to create unwanted version when the stem is being implanted into the bone as you're unable to control the angle/version of the stem with the stem inserter.Surgery completed as planned, no adverse event/patient outcome.

• Brand Name: SUMMIT STANDARD IMP. INSERTER
• Type of Device: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr; warsaw IN 46581
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 46581-0988 ; 6103142063
• MDR Report Key: 9427525
• MDR Text Key: 184388160
• Report Number: 1818910-2019-121590
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 10603295143215
• UDI-Public: 10603295143215
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 257005100
• Device Lot Number: CV0606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1