MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI 12-POINT NUT-11MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 499.294

Device Problem Difficult To Position (1467)

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

Event Date 06/09/2014

Event Type  malfunction  

Event Description

It was reported that during a posterior l5 ¿ s1 fusion a nut cross threaded onto a screw in the right l5 position.The surgeon was performing the posterior l5 ¿ s1 fusion on the patient using titanium universal spine system dual opening during surgery on (b)(6) 2014.It was reported that the surgeon placed 8.0 x 50mm screws in s1 and 7.0 x 50mm screws in l5.After the screws were inserted, the surgeon performed the decompression.The surgeon then connected the rods (498.290 rod cut into 2 rods to be used on both sides).While connecting the rods, the surgeon could not get the nut to thread onto the screw located at the right l5.It was reported that the nut became cross threaded onto the screw.The surgeon then tried another nut and a collar on the right l5 screw.The new nut became cross threaded.The surgeon then tried another nut and it threaded onto the screw.The procedure was completed successfully.No patient harm was reported.There was a ten minute time delay.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Additional product codes: mni, mnh, kwp, kwq.Device cross threaded during insertion; device was not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing evaluation was completed: the device was received with the anodize missing on part of the flange and the first m8 thread in the flange end side of the nut.This is not manufacture related.All relevant features were verified and conformed to product specifications.In addition, since the thread gage fit, the complaint condition of cross threaded cannot be confirmed.A product development evaluation was completed: the device was received with damaged threads near the base of the nut and the anodized finish has been removed from the damaged section of the threading.These 12 point nuts-11mm (lot 7633319) were manufactured in march 2014.A review of the most current edition of the design drawing was performed.The design is adequate for its intended use and did not contribute to this complaint condition.The cause of the complaint may have been due to the rod not being fully seated in the screw.If the nut is not placed proper aligned with the mating pedicle screw threads, cross-threading can occur damaging the screw and nut.The set contains instruments to help persuade/bend the rods to accommodate a wide variety of surgical instances and patient anatomy.Since there is not enough information concerning the placement of the rod during the procedure, this complaint is a deemed invalid from a design perspective.This complaint is confirmed, given the damage to the inner threads of these implants.The cause of the complaint may have been due to the rod not being fully seated in the screw.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI 12-POINT NUT-11MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3915335
• MDR Text Key: 4488555
• Report Number: 2530088-2014-10176
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 499.294
• Device Lot Number: 7633319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 66