MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENT/TRIAL

Catalog Number 221750041

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this 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

It was reported that the 52mm cup could not be removed from an inserter and two surgeons managed to remove it.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Manufacturer Narrative

Device available for evaluation.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination of the returned device confirms the complaint of handle damage; 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 via sep-419 post market surveillance.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

• Brand Name: PINN STRAIGHT CUP IMPACTOR
• 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: 5687198
• MDR Text Key: 46164277
• Report Number: 1818910-2016-20137
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• 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,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221750041
• Device Lot Number: J0310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2010
• 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