MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN STRAIGHT CUP IMPACTOR; HIPS INSTRUMENTS

Catalog Number 221750041

Device Problem Peeled/Delaminated (1454)

Patient Problem No Information (3190)

Event Date 09/29/2015

Event Type  malfunction  

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).

Event Description

The cup impactor threads are stripped.

Manufacturer Narrative

Examination of the returned instrument confirms damage to the threaded tip.Based on the evidence present the root cause is attributed to heavy use / use error.The impactor appears to have been used when not threaded into the mating cup as intended.Based on the investigation, the need for corrective action is not indicated.Continue to monitor via sep-419.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: HIPS INSTRUMENTS
• 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: 5144120
• MDR Text Key: 28451794
• Report Number: 1818910-2015-32564
• 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: Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 221750041
• Device Lot Number: NT1008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2008
• 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