MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENT/TRIAL

Catalog Number 221750041

Device Problems Crack (1135); Material Separation (1562)

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

Event Date 10/28/2015

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

Event Description

The white plastic part of the impactor handle has multiple cracks through out and is starting to separate into fragile pieces.

Manufacturer Narrative

The instrument associated with this report was not returned for examination.Based on the provided problem description the root cause may be design related.Previous investigations found design is attributed to the handles cracking; (b)(4) was implemented on january 3, 2008 to change the material from radel to aluminum.The vendor date code j1105 indicates the instrument was manufactured in november 2005 and is over 8 years old, made prior to these changes.Recently, (b)(4) was implemented that further changed the material from aluminum to overmoulded silicon.Further corrective action is 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: PINN STRAIGHT CUP IMPACTOR
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5189513
• MDR Text Key: 30242396
• Report Number: 1818910-2015-34072
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• 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: J1105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2005
• 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