MAUDE Adverse Event Report: SYNTHES TUTTLINGEN SINGLE LOCKING DRILL GUIDE

Catalog Number	387.286
Medical Device Problem Codes	Corroded (1131); Material Fragmentation (1261); Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(6).The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: (b)(4).Date of manufacture: jul 27, 2012.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 reported an event in (b)(6) as follows: it was initially reported that rust was detected on the surface at the tip of a drill sleeve during cleaning process.There was no reported patient or procedural involvement associated with the reported event.Upon initial inspection of the returned device on december 23, 2016 it was observed that a small portion of the tongs was broken off and missing.It is unknown when the reported issues occurred.This event was reassessed for reportability based on this additional finding.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: a product investigation was performed.The investigation of the self-holding drill sleeve has shown some rust at the front part of the instrument.The visible traces can easily be removed mechanically.Therefore, we can clearly state that this is a matter of accumulation of contact corrosion.Additional it was found that one small part of tongs is broken off.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features, for function and for surface at the final inspection.The reason which has led to this occurrence could not be identified.An unforeseen mechanical overload situation which was applied onto the tip cannot be excluded.Regarding corrosion it can be stated, that all materials, including so called stainless steel as well, are conditionally only rust-resistant.The corrosion resistance is maintained only, when the material is stored on a dry and metallic contactless condition.All metallic contacts on humid or wet condition create electrolytic reactions with contact corrosion as result.No product fault could be detected.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: SINGLE LOCKING DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6253359
• Report Number: 9680938-2017-10002
• Device Sequence Number: 60937
• Product Code: FZX
• UDI-Device Identifier: 10705034770994
• UDI-Public: (01)10705034770994(10)T976527
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2016

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: 387.286
• Device Lot Number: T976527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1