MAUDE Adverse Event Report: SYNTHES BETTLACH T25 STARDRIVE SCRWDRVR SHAFT 100MM; SCREWDRIVERS

Catalog Number	03.900.042
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id/initials, age/date of birth and weight are unknown.Device is an instrument and is not implanted/explanted.Contact phone number: (b)(6).Manufacturing location: (b)(4).Manufacturing date: september 08, 2016.No non-conformance reports 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.The device was received, the investigation could not be completed, and 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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the screwdriver shaft is twisted around its axis.This was detected intra-operatively; the procedure successfully completed.No information available about patient condition and outcome.When the device was received by the manufacturer, it was noted that the screwdriver shaft is broken.This is report 1 of 1 for (b)(4).
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 per the specifications and there were no issues that would contribute to this complaint condition.Lot l064146 was manufactured in september 2016 and all parts were per our specifications.The used material was stainless steel 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.The damage at the tip indicates that a mechanical overloading situation during screw removal is most probably the reason 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: T25 STARDRIVE SCRWDRVR SHAFT 100MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6796880
• Report Number: 9612488-2017-10406
• Device Sequence Number: 831929
• Product Code: HXX
• UDI-Device Identifier: 07611819791022
• UDI-Public: (01)07611819791022(10)L064146
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

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: 03.900.042
• Device Lot Number: L064146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1