MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T25 STARDRIVE SHAFT F/MATRIX CANNULATED/STANDARD; SCREWDRIVERS

Catalog Number	03.632.003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no patient involvement.It is unknown when device became stripped.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.No combination could be found for part 03.632.003 with lot 669804, therefore a dhr review could not be performed at this time.If further information becomes available regarding the identifies for this part, then this dhr review will be revisited.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, 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
(b)(6) reports that on (b)(6) 2018, as the nurse was setting up the table for a posterior spinal fusion surgery done minimally invasive (mis), the screwdriver shaft was found stripped at the distal end.The nurse set aside the screwdriver as others are present in the set and the surgery went on as planned.The procedure was completed successfully with no surgical delay.There was no patient involvement.This report is for a t25 stardrive shaft f/matrix cannulated/standard.This is report 1 of 1 for (b)(4).

• Brand Name: T25 STARDRIVE SHAFT F/MATRIX CANNULATED/STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7687417
• Report Number: 2939274-2018-52875
• Device Sequence Number: 11112243
• Product Code: HXX
• UDI-Device Identifier: 10705034718682
• UDI-Public: (01)10705034718682
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: 03.632.003
• Device Lot Number: 669804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1