MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Catalog Number 03.617.902

Device Problems Use of Device Problem (1670); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Additional pro-code: kwq.Received - not final destination.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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.(b)(4).

Event Description

Device report from synthes reports an event in (b)(6) as follows: the tips of these drivers got stripped during screw insertion.No fragments generated, charge replacements are needed surgery was not delayed due to the reported event, procedure was successfully completed.Unknown patient status/ outcome / consequences, if they were removed easily without additional intervention.Unknown other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision).The surgery was completed with these drivers but were taken out of the set.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity # 1); unknown holding sleeve (part # unknown, lot # unknown, quantity # 1).This complaint involves two (2) devices.This report is one (1 ) screwdriver shaft t8 self-hold.This report is 2 of 2 for (b)(4).

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.Additional narrative: part: 03.617.902-us.Lot: l817700.Manufacturing site: (b)(4).Release to warehouse date: may 24, 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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 t8 self-hold was received at us customer quality (cq).The distal tip of the screwdriver was discolored and twisted.The tip was twisted in the direction of tightening.There were light surface scratches along the shaft and there were marks on the coupling that were consistent with normal wear.The received condition is consistent with the complaint condition thus the complaint is confirmed dimensional inspection: shaft diameter proximal to damage was measured result = conforming manufacturing record evaluation: the received scrdriver shaft t8 self-hold was manufactured at the (b)(4) site on may 24, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Conclusion: the complaint was confirmed for the received scrdriver shaft t8 self-hold as the distal tip was discolored and twisted in the direction of tightening.Although no definitive root-cause can be determined, it is possible that the device experienced unintended forces during use such as over torque as evidenced by the direction of twisting.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.Corrected data: 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: STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8937556
• MDR Text Key: 195555759
• Report Number: 2939274-2019-60141
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 07611819969742
• UDI-Public: (01)07611819969742
• Combination Product (y/n): N
• PMA/PMN Number: K152239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.617.902
• Device Lot Number: L817700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 09/09/2019
• Patient Sequence Number: 1