MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T4/66MM; SCREWDRIVERS

Catalog Number	03.114.010
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth, age, and weight not available for reporting.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.(b)(4).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) 2017, two (2) stardrive screwdriver shaft t4/66mm would not engage on the heads of the 1.5mm module cortex screws.Because of this the surgeon had to remove the plate and screws.Patient did not receive a plate on finger.Instead, two (2) kirschner wires were used.There was a surgical delay of about 5 minutes.The procedure was successfully completed with patient in stable condition.Concomitant devices reported: cortex screw (part number unknown, lot number unknown, quantity unknown), plate (part number unknown, lot number unknown, quantity 1) (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.The returned instrument was examined and the complaint condition was able to be confirmed as the stardrive screwdriver shaft tip was found to be deformed.The complaint condition cannot be replicated due to post-manufacturing damage.The stardrive screwdriver shaft (03.114.010) is a component of both the 1.5mm modular lcp system and the 1.5mm lcp modular mini fragment system.In each instance, the t4 driver shaft is utilized for insertion or removal of screws.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number.Device history records review was completed for part# 03.114.010, lot# 7413800.Manufacturing location: (b)(4), release to warehouse date: oct 09, 2013.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No definitive root cause was able to be determined.However, the failure mode is consistent with the application off-axis/excessive force and/or wear and tear of a multiuse instrument.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: STARDRIVE SCREWDRIVER SHAFT T4/66MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7084833
• Report Number: 2939274-2017-50150
• Device Sequence Number: 1895816
• Product Code: HXX
• UDI-Device Identifier: 10886982073044
• UDI-Public: (01)10886982073044(10)7413800
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.114.010
• Device Lot Number: 7413800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention