MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCRDRIVER SHAFT T8 SELF-HOLD; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number 03.617.902

Device Problems Device Operates Differently Than Expected (2913); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient information is available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(6) reported that the tips of the screwdrivers all were found worn out and stripped intraoperatively during an unknown procedure on (b)(6) 2018 during the screw insertion and final tightening process.No surgical delay was noted.Procedure was completed successfully.Patient status is unknown.Concomitant devices: unknown screws (item number unknown, lot number unknown, quantity unknown).This is report 3 of 6 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.Date returned to manufacturer.Dhr review was completed.Part no.: 03.617.902 , lot no.: 7825504 , manufacturing location: haegendorf , release to warehouse date: 10.May.2012.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The stardrive screwdriver shaft t8, self-retaining/qc, (03.617.902) is one of four t8 screw insertion drivers in both the zero-p and zero-p variable angle (va) systems.The zero-p system notes that a 1.2 nm torque limiting attachment (03.110.002.99) must be used for screw insertion, cautioning: ¿if the torque limiting attachment is not used, breakage of the driver may occur, potentially increasing risk to the patient¿.When inserting screws in the va system, no torque limiting attachment is necessary as the screw head is retained by a blocking mechanism once fully inserted.For removal it is noted that a torque limiting attachment should not be used.The returned instrument was examined and the complaint condition was able to be confirmed as the distal drive tip was found to be stripped.No definitive root cause was able to be determined; the failure mode is typically associated with rough handling and/or the application of excessive force during screw insertion.Whether or not the complaint condition was able to be replicated is not applicable due to post-manufacturing damage.Relevant drawings for the returned instruments were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.No dimensional analysis was possible due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Date reported in initial report was 4/6/2018.Correct date should have been 3/21/2018 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: SCRDRIVER SHAFT T8 SELF-HOLD
• Type of Device: 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: 7428200
• MDR Text Key: 105382047
• Report Number: 2939274-2018-51650
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034717166
• UDI-Public: (01)10705034717166(10)7825504
• 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: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.617.902
• Device Catalogue Number: 03.617.902
• Device Lot Number: 7825504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1