MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. EXCEL T-HANDLE; HIP INSTRUMENT/TRIAL

Catalog Number 200142000

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The instrument is cracked.Update jan 23, 2017 - upon product evaluation, the instrument handle is cracked.

Manufacturer Narrative

Examination of the returned device confirms the reported observation; the handle is cracked.A complaint database search on the provided product code identified similar reports for handle damage/breakage.A previous evaluation found the t-handles are cracking due to environmental stress cracking.This is due to the combination of normal loading or usage of the instrument and exposure to chemicals they are not intended to be (non-compliant to cleaning guidelines) leading to weakening of the material over time.Based on the determination of environmental stress cracking as the root cause, no further corrective action is being pursued at this time.Continue to monitor complaints under post market surveillance (b)(4).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: EXCEL T-HANDLE
• 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: 6290016
• MDR Text Key: 66166139
• Report Number: 1818910-2017-11700
• Device Sequence Number: 1
• Product Code: FZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200142000
• Device Lot Number: SO2019557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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