MAUDE Adverse Event Report: SYNTHES BRANDYWINE CANCELLOUSSCR SYNAPSE Ø4.5 L36 F/R Ø4 TA; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.615.236S

Device Problem Break (1069)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Date returned to manufacturer.(b)(6) subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4), packaged by: (b)(4).Manufacturing date: 16-jan-2015.Expiration date: 31-jan-2025.Part #: 04.615.236s, lot#: 7893746 (sterile) - 4.5mm ti cancellous polyaxial screw 36mm for 4.0mm rod.Qty: 12.Components part 04.615.236y lot 7879151 reviewed.(b)(4) implant meet inspection sheet.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that the screw head broke off while the surgeon inserted the rod to the cancellous bone screw,.While inserting the screw head, it had loosened from the shaft, the screw shaft had to be removed from the vertebral body with forceps.The surgery prolongations of 30 minutes were reported.No information available about patient condition and the outcome.This complaint involves 1 part.Concomitant reported part: 1x unknown insertion instrument, 1x unknown rod, part/lot unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (cancellousscr synapse ø4.5 l36 f/r ø4 ta, part number 04.615.236s, lot number 7893746).Customer quality (cq) engineering investigation: the polyaxial head was found to be dislocated to the distal end of the screw body.The complaint is confirmed.The complaint condition could not be replicated due to visible damage.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.Visual inspection: the polyaxial head was found to be dislocated to the distal end of the screw body.There are no broken and/or missing fragments.Ployaxial head shows some scratch marks on the surface which may have caused during the attempt to remove the screw.The stardrive recess of the screw head looks stripped, indicating application of excessive torque.Threads towards the upper half body of the screw are damaged, most probably due to friction experienced when polyaxial head slid downwards.The screw assembly is not broken but disassembled.Drawing review: 4.5mm ti toploading cancellous screw drawing 04_615_208 were reviewed.It was observed that the returned matrix screw was manufactured per the drawing.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.Complaint condition was most probably an outcome of user error and/or improper technique.As per synapse system technique guide, tip of the stardrive screwdriver shaft is inserted into the recess of the bone screw of the polyaxial screw.This is followed by screwing threaded holding sleeve into the polyaxial head.It is possible that excessive force was applied on the holding sleeve during screw insertion which pushed down the polyaxial head and led to the complaint condition.Unable to determine an exact root cause.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional device product codes: kwp, mnh, mni.Corrected data: udi: (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 Description

It was reported that the surgery of synapse system was implanted from c5-6 to th 1-2.

• Brand Name: CANCELLOUSSCR SYNAPSE Ø4.5 L36 F/R Ø4 TA
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6817728
• MDR Text Key: 83749424
• Report Number: 2530088-2017-10257
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.615.236S
• Device Lot Number: 7893746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 09/20/2017; 10/26/2017
• Supplement Dates FDA Received: 09/26/2017; 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1