MAUDE Adverse Event Report: SYNTHES BRANDYWINE CANNULATED STARDRIVE SCREWDRIVER/T15; SCREWDRIVERS

Catalog Number	314.114
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.A product development investigation was performed for the subject device (cannulated stardrive screwdriver/t15, part number 314.114, lot number 6108286).The subject device was returned with the complaint condition stating: a visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed at cq for the returned device as part of this investigation.No product design issues or discrepancies were observed.Visual inspection at cq confirmed the reported complaint condition.The distal stardrive lobes are worn.The edges show cumulative wear.Additionally, the tip is slightly twisted approximately 15-20 degrees in the direction of resistance met during screw insertion.A functional test could not be performed at cq as the screw involved in the event was not returned.Screwdriver assembly and screwdriver shaft component drawing were reviewed during this investigation.No product design issues or discrepancies were observed.The stardrvie tip features could not be accurately measured at cq due to the post manufacturing damage (twisted and worn).The inside diameter / cannulation at the distal tip measured 1.73 mm at cq (best fit gauge pin gp32) which is within specification of 1.70 mm - 1.80 mm per screwdriver shaft component drawing.Unable to determine a definitive root cause.Most likely due to excessive force as evidenced by the twisted tip.A device history record review was performed for the subject device lot number 6108286.Manufacturing location: (b)(4).Date of manufacture: 20 mar 2009.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported during an open reduction internal fixation (orif) of the proximal humerus that a cannulated stardrive screwdriver was worn so it would not seat with the screw.Another screwdriver was readily available and the surgery continued with no delay, no medical intervention and was successfully completed.The patient was stable following the surgery.Concomitant medical device: unknown screw (quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: CANNULATED STARDRIVE SCREWDRIVER/T15
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 7007006
• Report Number: 2530088-2017-10327
• Device Sequence Number: 1599934
• Product Code: HXX
• UDI-Device Identifier: 10886982188526
• UDI-Public: (01)10886982188526(10)6108286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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: 314.114
• Device Lot Number: 6108286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR