MAUDE Adverse Event Report: DEPUY SYNTHES SPINE TFP STRAIGHT; MANUAL, SURGICAL GENERAL USE

Catalog Number 286565000

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

Dr.(b)(6) was in the process of putting the screws into the vertebral bodies through a swift plus plate.He inserted 2 screws and proceeded to remove the temporary pin he had previously placed.The pin would not come out easily.Once he was able to remove it, we discovered the pin had broken off into the vertebral body.After considering options, dr.(b)(6) decided it would cause more than good to try and retrieve the broken part of the pin; the rest of the case was routine.Surgical delay of 5 minutes or less reported.

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not returned for evaluation.

Manufacturer Narrative

Complaint is a duplicate.Complaint previously reported in com-(b)(4).Follow up medwatch submitted.Complaint voided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complaint duplicate.

• Brand Name: TFP STRAIGHT
• Type of Device: MANUAL, SURGICAL GENERAL USE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4921884
• MDR Text Key: 15899655
• Report Number: 1526439-2015-10649
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 286565000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR