MAUDE Adverse Event Report: SYNTHES HAGENDORF STARDRIVE SCREWDRIVER/T25 240MM W/GROOVE

Catalog Number	314.164
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient age, dob & weight not provided for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Reporters phone number: (b)(6).Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4).Manufacturing date: 02.March 2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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
Device report from synthes on an event in (b)(6) as follows: it was reported that a screwdriver is broken during surgery.It broke into the screw and they couldn¿t take out this piece from the screw.Fragments were generated.Procedure successfully completed.No delay to surgery time.No patient harm.This complaint involves one part.Concomitant parts reported: 1x unk screw, part unk, lot unk.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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
A product investigation was performed.The investigation of the complained screwdriver shows that the tip is badly twisted in the direction of screw removal and furthermore approx.2mm at the forefront is broken off.The broken off portion is missing.Because of the damage the complaint relevant dimensions cannot be checked to print specifications anymore.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Lot 9835610 was manufactured in march 2016 and all parts were according to our specifications.The used material was stainless steel custom as required and the measured harness was within the specification.The broken surface is homogenous what indicates material conformity as well.Therefore a manufacturing issue can be excluded.Mechanical overloading during screw removal is most probably the root cause for the breakage and deformation.No indication for product related issue was found.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/T25 240MM W/GROOVE
• Common Device Name: STARDRIVE SCREWDRIVER/T25
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6622866
• Report Number: 3003875359-2017-10278
• Device Sequence Number: 738847
• Product Code: HXX
• UDI-Device Identifier: 07611819159471
• UDI-Public: (01)07611819159471(10)9835610
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2017

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: 314.164
• Device Lot Number: 9835610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: Not provided; 07/10/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 06/26/2017; 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1