MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SUMMIT STANDARD IMP. INSERTER; HIP INSTRUMENT/TRIAL

Catalog Number 257005100

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Connection Problem (2900); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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

On insertion of the new 135 deg short neck the inserter became fixed to the implant and would not disconnect.The stem was disconnected and reseated using an alternative impactor.On inspection the impactor tip appears to have changed shape which is why it seems to have locked on the stem during impaction.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

No products have been returned for examination.It is difficult to draw conclusions from the provided instrument photographs; however the tip of the inserter appears damaged, likely through repeated use over time.The provided lot code of cv0305 signifies manufacture in march of 2005 and so this instrument has been in-service for more than ten years.If the instrument tip becomes damaged over time it will have an effect on how it fits within the mating femoral stem.A complaint database search against the femoral stem product / lot combination finds no previous reports of any kind.The root cause is attributed to damage to the instrument from repeated use.Corrective action not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SUMMIT STANDARD IMP. INSERTER
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6188670
• MDR Text Key: 63206161
• Report Number: 1818910-2016-33697
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 257005100
• Device Lot Number: CV0305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2005
• 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