MAUDE Adverse Event Report: DEPUY SYNTHES SPINE FAVORED C/C MINIPOLY SCREW 3.5 X 3.5 X 12MM (SUMT); ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 188318312

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Event Description

I had an incident that happened tuesday with mountaineer.When dr (b)(6) final tightened the outer nut it pulled the inner set screw out of the screw and tore the threads off of the inner set screw.We tried 4 other inner set screws and it happened every time.We then realized that the inner threads of the 12mm fa screw were ripped off as well.So we replaced the 12mm screw with a new one.Tried the process again.It still pulled the inner set screw out of the screw head.So we bailed on the cross link.We examined the inner threads of the 12mm screw and they seemed fine so we put in a regular set screw.The regular set screw worked fine.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The mountaineer f/a polyaxial screw [product code: 1883-18-312, lot number: armb97] was returned for evaluation.Visual examination revealed that the threads of the polyaxial tulip head were torn.Dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A review of the complaint trend analysis was performed and no emerging trends were identified as a result of the analysis.The root cause for the threads inside the tulip head becoming torn cannot be positively determined.A potential root cause may be inadvertently cross threading the inner screws upon insertion, leading to the threads of the tulip head becoming damaged during tightening attempts.No issues were identified during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A trend analysis was conducted.No further actions from trending analysis are required; therefore this complaint file will be closed with no further action required.

• Brand Name: FAVORED C/C MINIPOLY SCREW 3.5 X 3.5 X 12MM (SUMT)
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4767982
• MDR Text Key: 5952369
• Report Number: 1526439-2015-10417
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK041203
• 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: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 188318312
• Device Lot Number: ARMB97
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 05/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1