MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC PINN CAN BONE SCREW 6.5MMX35MM; HIP OTHER IMPLANT

Catalog Number 121735500

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

Head of pinnacle screw broke off during insertion into acetabulum.

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

Examination of the reported device was not possible as it was not returned.A search of the complaints databases identified no similar or related reports against the provided product/lot code combination.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.Additional event information and investigational inputs were requested but not provided.The investigation can draw no conclusions with the information provided.Based on the inability to determine a root cause, the need for corrective action has not been indicated.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.

• Brand Name: PINN CAN BONE SCREW 6.5MMX35MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4134210
• MDR Text Key: 4921591
• Report Number: 1818910-2014-29268
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121735500
• Device Lot Number: D14031962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 96