MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.7 TI CERV SPINE SCREW SLF-TPNG/VA 16MM; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

Model Number	04.647.876
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 3 of 3 for (b)(4).It was reported by the sales rep in (b)(6) that during an unknown surgery on an unknown date, it was observed that the fusion cage device was unstable in its rotation and could not be used.According to the report, two screw devices were wasted as a result.Another like devices were used to complete the procedure with a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.This report is for one (1) 3.7 ti cerv spine screw slf-tpng/va 16mm device.This complaint involves three (3) devices.
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.The lot number was unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 3.7 TI CERV SPINE SCREW SLF-TPNG/VA 16MM
• Common Device Name: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14137470
• Report Number: 2939274-2022-01343
• Device Sequence Number: 6291088
• Product Code: OVE
• UDI-Device Identifier: 10705034751429
• UDI-Public: 10705034751429
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 04.647.876
• Device Catalogue Number: 04.647.876
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown