MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED STARDRIVE SCREWDRIVER/T15; SCREWDRIVERS

Catalog Number	314.114
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a synthes sales consultant part 314.114, lot 7450202: release to warehouse date: august 12, 2013.Manufactured by synthes (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was completed: visual inspection of the returned device confirmed the condition of a damaged tip, which agrees with the reported complaint condition.The distal cannulated t15 tip is significantly twisted (post manufacturing damage) in the direction of resistance encountered during screw insertion.No other damage was observed.The returned device was manufactured in august 2013 and is over five (5) years old.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The relevant design drawings were reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.The inside diameter of the returned screwdriver at twisted distal cannulated tip measured within specification.A dimensional inspection of the external features of the returned distal t15 tip could not be accurately measured due to the post manufacturing damage (significantly twisted).The shaft outside diameter of the returned screwdriver just proximal to the twisted distal cannulated tip measured within specification.A definitive root cause for the tip twisting could not be determined based on the provided information.The most likely cause is excessive resistance encountered during screw insertion.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 an unknown orthopedic procedure on (b)(6) 2018, the t15 cannulated screwdriver that is on cannulated screw set was found damaged.It is unknown when the issue happened.It was unknown if there was a surgical delay.Patient and procedure outcome was unknown.During investigation of the returned device it was noted the distal cannulated t15 tip is significantly twisted (post manufacturing damage) in the direction of resistance encountered during screw insertion.This report is for a cannulated screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: CANNULATED STARDRIVE SCREWDRIVER/T15
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8197145
• Report Number: 2939274-2018-55580
• Device Sequence Number: 13994569
• Product Code: HXX
• UDI-Device Identifier: 10886982188526
• UDI-Public: (01)10886982188526
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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: 314.114
• Device Lot Number: 7450202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1