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

Catalog Number	03.240.002
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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
It was reported during an open reduction internal fixation (orif) of the left proximal humerus on (b)(6) 2018, three (3) separate cannulated stardrive screwdriver shafts became twisted and would not properly seat in the screw recess.Surgery was completed with no delay.Patient outcome reported as good.This report is for one (1) cannulated stardrive screwdriver shaft.This is report 3 of 3 for (b)(4).
Additional Manufacturer Narrative
The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record (dhr) review was performed for part#: 03.240.002, synthes lot#: 5696044: release to warehouse date: 6/11/2008, manufacturing location: supplier - universal punch: 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 performed.Visual inspection confirmed the reported complaint condition.The distal tip is worn and also significantly twisted in the direction of resistance met during screw insertion.Additionally, the part# and lot# etch are worn/barely legible.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition.No new malfunctions were identified as a result of the investigation.The returned cannulated screwdriver shaft was manufactured in june 2008 and is over 9 years old.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The 03.240.002 t15 cannulated stardrive screwdriver shaft is a reusable instrument routinely used in the 3.7mm cannulated locking and conical screws.A dimensional inspection of the t15 stardrive outer geometry could not be accurately obtained at cq due to the post manufacturing damage (twisted).The inside diameter at the distal twisted tip measured at cq which is within specification per relevant drawing.The most likely cause for this complaint is cumulative wear and over torqueing of the returned 9+ year old screwdriver shaft under power during attempted screw insertion.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: CANNULATED STARDRIVE SCREWDRIVER SHAFT/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: 7393108
• Report Number: 2939274-2018-51414
• Device Sequence Number: 1094511
• Product Code: HXX
• UDI-Device Identifier: 10886982077523
• UDI-Public: (01)10886982077523(10)5968044
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2018

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: 03.240.002
• Device Lot Number: 5968044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 05/04/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 04/26/2018; 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 71