MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANCELLOUSSCR SYNAPSE 4.5 L26 TAN; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.614.226
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procodes: kwp, mnh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in (b)(6) as follows: it was reported a posterior cervical fusion from c2-c5 procedure using the synapse system 3.5mm occurred on (b)(6) 2019.Upon inserting the c2 screws, the surgeon noted that the head of the screw broke and become completed separated from the shaft of the screw.It was noted that the patient's bone was very hard.Tapping did take place at that level, however the surgeon was only able to tap half way.The shaft of the screw was removed and another screw inserted.Procedure was completed successfully with no surgical delay.Both the head and the shaft were retrieved from the patient concomitant devices reported: unk - awls/taps: spine (part#: unknown, lot#: unknown, quantity#: unknown).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the cancel lousscr synapse ø4.5 l26 tan (p/n 04.614.226, lot number h772519) was received at us customer quality (cq).Visual inspection of the compliant device showed the tulip head, bushing, and sleeve have separated from the screw shank, and the ball head of the screw was scuffed.Functional test: a functional test was unable to be performed due to post-manufacturing damage.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: screwball head diameter = 4.69 +/- 0.02 mm.Measured dimensions: screwball head diameter = 4.67 mm, conforming.Device used ¿ caliper ca802.Specified dimensions: screw length = 29.5 +/- 0.2 mm.Measured dimensions: screw length = 29.54 mm, conforming.Device used ¿ caliper ca802.Document/specification review: manufactured and current drawings were reviewed.This drawing covers 22 different length screws.No design issues or discrepancies were identified.Complaint confirmed? yes.Device history review (dhr) completed for this lot, no nonconformances found.The dhr shows that this lot was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all-dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation conclusion: this complaint is confirmed as the cancellous screw has separated into two parts but has not broken.No definitive root cause could be determined based on the provided information.However, it is possible the failure happened from the insertion hole not being tapped all the way, an extreme angle of insertion, or the patient's bone being too hard for the screw to adequately function.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 4.5 L26 TAN
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9261485
• Report Number: 2939274-2019-61863
• Device Sequence Number: 2550489
• Product Code: NKG
• UDI-Device Identifier: 10705034738840
• UDI-Public: (01)10705034738840
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 04.614.226
• Device Catalogue Number: 04.614.226
• Device Lot Number: H772519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - AWLS/TAPS: SPINE