MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.613.516
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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
It was reported on (b)(6) 2020, the 16mm vectra screw went through a 45mm vectra t plate screw hole, and the clip broke intraoperatively.Fragments were removed easily without additional intervention.There was a surgical delay of five (5) minutes.The procedure was successfully completed.This is report 2 of 2 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.H3, h6: a product investigation was conducted.Visual inspection: the 4.0 mm ti cerv self retain screw (p/n: 04.613.516, lot #: unk) was returned and received at us cq.Upon visual inspection, it was observed that the device was received assembled with ti vectra-t(tm) plate 3 level/45 mm on the right slotted hole of the base plate.No other issues were identified with the returned device.Functional test: during the functional test, an attempt to disassemble the 4.0 mm ti cerv self retain screw (p/n: 04.613.516) failed.This could have been caused due to the broken wishbone clip.Further functional testing of device interaction issues were not performed due to received condition of the device.Unable to perform full functional test due to received condition of the device but the received condition of the device does not agree with the complaint description and is not confirmed as no issues were observed on the returned device.The mating device was noted to be broken which caused the complaint condition.Dimensional inspection: a dimensional inspection was not performed as the complaint relevant dimensions were inaccessible without destruction of the mating device.Document/specification review: since the exact manufactured date of the device was not identified, the current revision of drawings were reviewed the mating device was noted to be broken which caused the complaint condition.Investigation conclusion: the complaint condition was not confirmed for the 4.0 mm ti cerv self retain screw (p/n: 04.613.516, lot #: unk) as no issues were identified with the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: 4.0MM TI CERV SELF-RETAIN SCR SLF-DRLG/VARIABLE ANGLE 16MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10670938
• Report Number: 2939274-2020-04634
• Device Sequence Number: 16826134
• Product Code: KWQ
• UDI-Device Identifier: 10705034737645
• UDI-Public: (01)10705034737645
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K071667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 04.613.516
• Device Catalogue Number: 04.613.516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI VECTRA-T(TM) PLATE 3 LEVEL/45MM; TI VECTRA-T(TM) PLATE 3 LEVEL/45MM