MAUDE Adverse Event Report: DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS PINN CAN BONE SCREW 6.5MMX25MM

Catalog Number 121725500

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 01/06/2014

Event Type  Injury  

Event Description

Surgeon performed the case to realign cup position due to malalignment.

Manufacturer Narrative

This complaint is still under investigation.Device not returned.

Manufacturer Narrative

Additional narrative: examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product/lot code combinations since their release to distribution.Additional event information and investigational inputs were requested but not provided.The initial reporting stated the patient was revised to address malpositioning of the acetabular component.Because no patient x-rays have been provided, no comment on positioning can be made.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS; 325 paramount drive; reg. # 1219655; raynham MA 02767
• Manufacturer (Section G): DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS; 325 paramount drive; reg. # 1219655; raynham MA 02767
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3562707
• MDR Text Key: 4211787
• Report Number: 1818910-2014-10361
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 121725500
• Device Lot Number: DW7CL4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 39 YR