MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC; SCREWDRIVERS

Catalog Number	03.614.019
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 posterior spinal fusion procedure, the surgeon was performing the final tightening on the synapse set screws.The distal tip of the stardrive screwdriver was stripped, and did not tighten the screws.Another stardrive screwdriver was available in the set, and it was used to complete the procedure.There was no surgical delay, no reported fragments generated, and no reported patient harm.This report is for a stardrive screwdriver shaft t15/self-retaining qc.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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
Concomitant medical products: titanium locking screws (part number unknown, lot number unknown, quantity unknown).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7506153
• Report Number: 2939274-2018-52132
• Device Sequence Number: 1556179
• Product Code: HXX
• UDI-Device Identifier: 10705034714905
• UDI-Public: (01)10705034714905
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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 Catalogue Number: 03.614.019
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1