MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX® EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE; SCREWDRIVERS

Catalog Number	03.835.015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.Date returned to manufacturer.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 patient was implanted with one (1) synfix evolution implant and four (4) screws on unknown date at unknown level.Patient was returned to surgery on (b)(6) 2018 for revision due to infection.During the removal procedure, four (4) synfix screwdrivers broke or were deformed while attempting to remove a screw.No fragments were generated.Surgery was delayed approximately 10 minutes.Revision surgery due to infection is addressed in (b)(4).This report addresses the intra-operative issues with the screwdrivers.This report is for one (1) synfix evolution screwdriver straight without sleeve this is report 4 of 4 for (b)(4).
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.Dhr review was completed.Part: 03.835.015, lot: l467634 , manufacturing site:hägendorf, release to warehouse date: 12 july 2017.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition customer quality conducted an investigation of the returned device.Pre-investigation statement: instrument is not broken but deformed.Investigation site: cq zuchwil , selected flow: 3.Damage: visual (appearance not as expected).Visual inspection: one synfix evolution screwdriver, w/o thread lock sleeve was returned for evaluation ( l467634).The visual inspection confirmed that the stardrive tip is damaged ¿ it is significantly twisted in the direction of resistance encountered during screw removal.Besides, the instrument is in good condition.Dimensional inspection: the relevant dimensions could not be checked due to the damage incurred.Document / specification review according to the relevant test instruction the correct material was used, and the hardness parameters were within the specification of min 52 hrc.The instrument is function checked per 100% at manufacture and passed.Summary : the complaint condition is confirmed as the stardrive tip is damaged ¿ it is significantly twisted in the direction of resistance encountered during screw removal.This production lot was manufactured in jul 2017 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The investigation found no manufacturing related issues that would have contributed to this complaint condition and we are not aware of any other complaints for this article- and lot combination.It was determined that the device became twisted due to post manufacturing damage which was likely caused by excessive force during screw removal.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: SYNFIX® EVOLUTION SCREWDRIVER STRAIGHT W/O SLEEVE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7795169
• Report Number: 8030965-2018-55811
• Device Sequence Number: 19225854
• Product Code: HXX
• UDI-Device Identifier: 07612334054364
• UDI-Public: (01)07612334054364
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 08/01/2018

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: 03.835.015
• Device Lot Number: L467634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/11/2018
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 95