MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER SHAFT 66MM T8 DEEP STARDRIVE/SOLID; SCREWDRIVERS

Catalog Number	SD314.121
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s identifier, date of birth/age and weight are unknown.Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 procedure on (b)(6) 2018, while the surgeon was applying the 2.4 mm variable angle lcp two-column volar distal radius plate onto the patient, he noticed that the screws were not ¿staying on¿ the stardrive screwdriver shaft t8 55mm like it normally does.The surgeon and the sales rep determined that the stardrive screwdriver shaft t8 55mm must have been warped which is why the screws kept falling off the stardrive screwdriver shaft t8 55mm.The surgeon opted to place the screws into the plate by hand to complete the procedure.There was no harm to the patient, however it did add approximately 5 minutes to the surgery.Concomitant devices reported: 2.4 mm variable angle lcp two-column volar distal radius plate (part # 02.111.631, lot # unknown, qty #1), unknown screws (part # unknown, lot # unknown, qty # unknown).This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part number: sd314.121, synthes lot number: 5738024, supplier lot number: n/a: release to warehouse date: 19 mar 2008, manufactured by synthes brandywine: mrr generated during production for incorrect heat treat specification called out on print; vendor supplied incorrect treatment and specification.100% inspection was performed and all 7 devices.The devices were released for use as is and noted to conform to specification as per the relevant mrr are interchangeable for 465pn material.This non-conformance is not relevant to the complaint condition as an interchangeable specification was used to heat treat the released devices and this would not impact the fit between the two devices.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was performed.Device condition: the device was received with the distal tip worn, and slightly twisted.The shaft of the device was received with numerous marks and striations consistent with use.The complaint condition is confirmed as the distal tip that interfaces with screws was damaged and worn.However, the condition could not be replicated or functionally tested as the mating screws were not received.Lot number review: record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The lot went through the required steps during the inspection at the time of manufacturing, including hardness check, and the dhr records showed no issues concerning the material.Release to warehouse date: 19-mar-2008 drawing review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed.A dimensional inspection was not applicable since the lobes of the device tip were visually confirmed to be deformed and damaged.The design history was found to not impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No definitive root cause was able to be determined as circumstances surrounding the event are unknown.It is likely that wear from use contributed to the wear and damage.Conclusion: a device history record (dhr) review, device inspection, and drawing review were performed as part of this investigation.The complaint condition is confirmed as the threads of the connecting screw are damaged.The device history record showed that there were no issues during the manufacture of this product and no product design issues or discrepancies were observed that may have contributed to the complaint condition.Thus, there is no indication that a design or manufacturing issue contributed to the complaint.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.

• Brand Name: SCREWDRIVER SHAFT 66MM T8 DEEP STARDRIVE/SOLID
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7289549
• Report Number: 2939274-2018-50731
• Device Sequence Number: 1741888
• Product Code: HXX
• UDI-Device Identifier: 10886982004741
• UDI-Public: (01)10886982004741(10)5738024
• 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,Followup
• Report Date (Section B): 01/27/2018

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: SD314.121
• Device Lot Number: 5738024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 01/27/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1