MAUDE Adverse Event Report: SYNTHES TUTTLINGEN MESH CUTTING SCISSORS LONG NOSE; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.503.037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Event date: unknown.Implant and explant dates: device is an instrument and is not implanted/explanted.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 history records review was conducted.The report indicates that the: manufacturing location: (b)(4).Part # 03.503.037, lot # t100974, manufacturing date: 20-dec-2013.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 96 parts of the lot were checked 100% for critical features and for function at the final inspection on 18-dec-2013.No ncrs were generated during production.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 that one of mesh cutting scissors long nose blades has broken off.The broken piece has been located.The issue was discovered in sterile processing.No patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: product development investigation has been completed.A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, device history record (dhr) review, technique guide(s) review and drawing review were performed as part of this investigation.This complaint is confirmed.The non-serrated jaw on the returned mesh cutting scissors has sheared off.The break occurred at the location of the screw/hinge.The thickness of the jaw at the location of breakage measured 2.82 mm (calipers ca592) at cq which is within specification of (b)(4) mm per drawing.The mesh cutting scissors are a reusable instrument used to cut mesh implants and are available for use in the matrixneuro system, the matrixmidface plating system, and the matrixcombo plating system as per the relevant technique guides.Relevant drawings were reviewed.No product design issues or discrepancies were observed.Root cause was determined as most likely due to aggressive handling at sterile processing.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: MESH CUTTING SCISSORS LONG NOSE
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6397590
• Report Number: 9680938-2017-10039
• Device Sequence Number: 16375067
• Product Code: LXH
• UDI-Device Identifier: 10887587011639
• UDI-Public: (01)10887587011639(10)T100974
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 02/16/2017

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: 03.503.037
• Device Lot Number: T100974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1