MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CANCELLOUSSCR SYNAPSE Ø3.5 L14 TAN; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.014S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: kwp, mnh and mni.Incident occurred intraoperative.Device was not implanted/explanted.Reporter contact number was not provided for reporting.The device was received and the product evaluation is in progress.No conclusion can be drawn.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, the surgery for cervical spondylotic myelopathy was performed using the synapse 3.5 system.The fixed area was c3 ¿ c6.During the surgery, the following events were confirmed and appropriate actions were taken by the surgeon.The surgeon inserted the screw and then placed a rod.At the time of final tightening, the patient¿s bone broke at the location where this screw was inserted.The surgeon extended the fixation up to c6 (left) due to a fracture of lateral mass at c5(left) and to deal with the broken bone.The surgery was completed with a 30-minutes delay, and there was no adverse consequence to the patient.The surgeon commented that he had no complaint about the product because the location of the bone tends to break easily, and that this event might be caused by his technical failure.This report is for one (1) 3.5mm ti cancellous polyaxial screw 14mm.(b)(4).

Manufacturer Narrative

Additional narrative: hospital telephone: (b)(6).Dhr review was completed.Part number: 04.614.014s synthes lot number: l209481.Manufacturing location: (b)(4), supplier: (b)(4).Release to warehouse date: 25.Nov.2016, expiry date: 01.Nov.2026 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.Non-sterile 04.614.014 / h215714 was manufactured in us.Dhr review product code: 04.614.014, synthes lot number: h215714, release to warehouse date: 19-oct-2016, manufacturing site: (b)(4).Ncr 1051925 initiated for part number 21018, lot number 7448020 for no billet ut inspection completed on certificate of testing.Deviation was submitted by supplier and accepted by synthes, and lot was dispositioned as conforms.Ncr is not related to the complaint condition of no reported product problem.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.Customer quality conducted an investigation of the returned device.The returned instrument (part 04.614.014s, lot l209481, mfg 25.Nov.2016) was inspected at customer quality and the complaint of no product problem was confirmed.Replication is not applicable for this complaint condition.Tabulated drawing (current and mfg) was reviewed and no design issues were identified.Upon visual inspection, it was noted that the screw head had light scratches consistent with insertion and removal.Dimensional analysis was completed, the diameter shaft just distal of the head, measured 2.50 mm.This is within specification of 2.45 to 2.55 mm, based on drawing.Dhr review showed no ncr¿s were generated during production.Material and relevant testing occurred at the time of manufacture and confirmed to have no issues through the dhr review.While no definitive root cause could be determined it is possible that the bone breakage occurred due to screw being inserted into an incorrectly oriented or dimensioned pilot hole or patient specific bone quality issues.Due to the serious injury, risk documents were reviewed and determined to adequately address the risk.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition, based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: CANCELLOUSSCR SYNAPSE Ø3.5 L14 TAN
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7125400
• MDR Text Key: 95172861
• Report Number: 8030965-2017-50777
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819327863
• UDI-Public: (01)07611819327863(17)261101(10)L209481
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.014S
• Device Lot Number: L209481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention