MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.7 TI CERV SPINE SCREW SLF-TPNG/VA 14MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	04.647.874
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.Part #: 04.647.874; synthes lot #: 8735607; supplier lot #: n/a; release to warehouse date: november 26, 2013; manufactured by: werk mezzovico; no ncr's generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the 3.7 ti cerv spine screw slf-tpng/va 14mm (part #: 04.647.874, lot #: 8735607) was received at us customer quality (cq).Visual inspection of the complaint device showed that the hexlobe on the screw head was deformed.The outer major thread was also deformed.The visual inspection also revealed that the thin metal ring reported in the allegation did not come from the screw.Functional test: a functional assessment was not performed with the complaint device due to the post manufacturing damage of the complaint device.Can the complaint be replicated with the returned device? unable to perform dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the visual inspection of the screw revealed that the hexlobe and the outer major thread were both deformed.The damage observed on the complaint device appeared to be post manufacturing.It is likely this damage occurred during the surgery and therefore contributed to the screw not being able to assemble with mating devices.No root cause could definitively be determined for the reported complaint condition.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 preventive 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.
Event or Problem Description
It was reported that, during a procedure, when inserting a screw into the zero p variable angle (va) implant a thin metal ring appeared to unspool when insertion torque was applied to the screw.Procedure was completed successfully with no surgical delay.No patient consequence.This report involves one (1) 3.7mm ti cervical spine screw slf-tpng/variable angle 14mm.This is report 2 of 2 for (b)(4).

• Brand Name: 3.7 TI CERV SPINE SCREW SLF-TPNG/VA 14MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12641559
• Report Number: 2939274-2021-06132
• Device Sequence Number: 3413483
• Product Code: OVE
• UDI-Device Identifier: 10705034751405
• UDI-Public: (01)10705034751405
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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: No Information
• Device Model Number: 04.647.874
• Device Catalogue Number: 04.647.874
• Device Lot Number: 8735607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1