MAUDE Adverse Event Report: SYNTHES MONUMENT STARDRIVE SCREWDRIVER SHAFT T4/66MM; SCREWDRIVERS

Catalog Number	03.114.010
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier, age or date of birth, and weight are not available for reporting.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review for part # 03.114.010, supplier lot # 6440427.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: 28-oct-2010.Supplier: (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, on (b)(6) 2017, during open reduction internal fixation (orif) surgery for a metacarpal fracture, the surgeon was having trouble inserting screws.The screws were spinning on the screwdriver.Upon inspection, the tip of the screwdriver appeared rounded, not broken.A back-up screwdriver was available to complete the surgery successfully.There was no surgical delay.Concomitant device reported: screw (part number unknown, lot number unknown, quantity unknown).This report is for one (1) stardrive screwdriver shaft.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: product development investigation was completed.The device was returned and reported that the tip had become rounded.This condition is confirmed; the star tips of the distal face of the shaft are worn down giving the face a rounder shape.It is likely that over six years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The device was manufactured in oct 2010 and is over six years old.The balance of the returned device is in fair condition with some additional signs of superficial wear.The 03.114.010 stardrive screwdriver shaft is an instrument routinely used in the 1.5mm lcp modular mini fragment system as per the technique guide.Relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6736348
• Report Number: 1719045-2017-10686
• Device Sequence Number: 2013579
• Product Code: HXX
• UDI-Device Identifier: 10886982073044
• UDI-Public: (01)10886982073044(10)6440427
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/23/2017

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: 03.114.010
• Device Lot Number: 6440427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREW (PART AND LOT UNKNOWN, QTY UNKNOWN)