MAUDE Adverse Event Report: DEPUY SYNTHES SPINE FAVORED C/C MINIPOLY SCREW 3.5 X 3.5 X 14MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 188318314

Device Problem Torn Material (3024)

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

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

Case date: (b)(6).Case occurs, there is some inter-operative difficulty, rep covering the case in unclear as to what took place on (b)(6): i have a follow up discussion with the surgeon who informs me of the following details, which clearly indicate a need to file an adverse event report: as surgeon was final tightening the cross connector cap, the head of the mountaineer screw appeared to splay open doing clear damage to the screw, and seemingly popping set screw out of bone screw.Screw, cap, nut, and cross link were all removed and replaced with new implants.

Manufacturer Narrative

(b)(4).The mountaineer 3.5x14mm favored angle screw (product code: (b)(4), lot number: atkbf0) was returned to the complaints handling unit (chu).All of the threads inside the tulip head of the favored angle screw were torn.The torn threads have all been torn evenly across their surface and have been completely separated from the body of the tulip head.No other damage to the screw was found.Due to the evenness of the damage and lack of any other harm to the screw, it is believed that the inner screw may have been cross threaded during insertion.Tightening the cross threaded screw subsequently resulted in the threads of the tulip head being torn in a uniform manner.It has been noted that the complaint description mentions that the damage to the screw was discovered while final tightening the inner screw.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the screw threads becoming torn cannot be positively determined from the sample and information provided.A potential root cause may be cross threading the associated inner screw.Tightening the screw in this configuration may have led to the threads being torn uniformly from the side of the tulip head.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FAVORED C/C MINIPOLY SCREW 3.5 X 3.5 X 14MM
• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5239840
• MDR Text Key: 31737182
• Report Number: 1526439-2015-10956
• 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: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 188318314
• Device Lot Number: ATKBFO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2015
• 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
• Treatment: MNTR H/H X-CONN OUTER NUT (B)(4) QTY 2