MAUDE Adverse Event Report: SYNTHES BRANDYWINE TI COLLAR WITH GROOVES; ORTHOSIS, PEDICLE SPINAL FIXATION

Model Number	498.011
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Additional product codes: mnh, kwp, kwq, nkb.Device malfunctioned intra-operatively and 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.Dhr review for part #498.011, synthes lot #9932900.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: 28-oct-2015, manufactured by synthes (b)(4).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.
Event or Problem Description
It was reported that three devices malfunctioned during a t4-l2 scoliosis procedure on (b)(6) 2017.During the procedure, a hook positioner had a chunk come out of the phenolic handle during malleting.The chunk was recovered easily.Later, a socket wrench with straight handle split into two pieces during malleting.All pieces were recovered.Finally, upon final tightening, the surgeon noticed that a titanium (ti) collar with grooves at t8 left was broken toward the end of the procedure.The broken device was easily and quickly removed and another collar was implanted.The procedure was completed with no patient harm.Concomitant devices reported: titanium nut 11mm width across flats (part 498.003, lot number unknown, quantity 1); 5.0mm titanium side-opening screw 35mm (part 498.535, lot number unknown, quantity 1); mallet (part number unknown, lot number unknown, quantity 1).This report is for one (1) titanium collar with grooves.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.The ti collar with grooves (part # 498.011, lot number 9932900), was returned with a portion of the collar broken off.An approximately 2.31 mm x 1.8 mm x 2.79 mm (l x w x h) piece of the collar is missing, the fragment was not returned.This complaint is confirmed.A visual inspection, dhr review, and drawing review were performed as part of this investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned devices are already broken.Although a definitive root cause could not be determined, it is likely that this complaint condition was due to excessive (cyclical) loading applied to the collar causing material fatigue and breakage.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: TI COLLAR WITH GROOVES
• Common Device Name: ORTHOSIS, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6737157
• Report Number: 2530088-2017-10231
• Device Sequence Number: 531550
• Product Code: MNI
• UDI-Device Identifier: 10705034788593
• UDI-Public: (01)10705034788593(10)9932900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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
• Operator of Device: Health Professional
• Device Model Number: 498.011
• Device Catalogue Number: 498.011
• Device Lot Number: 9932900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 08/07/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/08/2017
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 44