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

Catalog Number	03.632.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event: it is unknown when device began to chip.Lot number is unknown.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.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
(b)(6) reports that during an unknown procedure on an unknown date, the surgeon found that the stardrive screw driver tips had become chipped with wear over time and it was difficult to tighten and twist the locking caps.There was no surgical delay reported.There is no reported patient consequence.Concomitant device: locking cap (part: unknown, lot: unknown, quantity: unknown) this report is for a sport grip t25 stardrive shaft f/matrix-standard.This is report 1 of 1 for (b)(4).

• Brand Name: SPORT GRIP T25 STARDRIVE SHAFT F/MATRIX-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: 7638071
• Report Number: 2939274-2018-52630
• Device Sequence Number: 2435778
• Product Code: HXX
• UDI-Device Identifier: 10705034718705
• UDI-Public: (01)10705034718705
• 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): 06/04/2018

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: 03.632.005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1