MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CABLE CUTTER; CUTTER,WIRE

Catalog Number	03.607.513
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: investigation site: (b)(4), selected flow: damaged: visual.Visual inspection: the corner above the stopper at the forefront of the cutter is broken off, the fragment was returned for evaluation.There are shiny marks on top of the stopper visible in the area where the breakage occurred.In general is the front cutter in a used condition, the cutting edges are slightly worn from use.Dimensional inspection: the relevant dimensions cannot be verified anymore due to the damage.Next to that it is very unlikely that a dimensional issue contributed to the breakage as the area where the breakage occurred is normally not exposed to any force.Drawing/specification review: drawing was reviewed to verify the material and hardness requirements of the cutter arm.The review of the manufacturing documents has shown that the device was made stainless steel and that the hardness was within the specification as required in drawing.Summary: the complaint condition is confirmed as the corner above the stopper at cutting jaw is broken off.During the performed evaluation no manufacturing related issue could be detected.The top of the stopper on the side of the cutter is usually not exposed to any force during the cutting procedure as there is a clear gap between the stopper and the broken corner in closed position.Therefore and as there are marks on the top of the stopper visible we have to assume that any obstacle was between the stopper and the corner during the cutting procedure which finally caused a mechanical overload.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 03.607.513, lot number: l874573, manufacturing site: (b)(4), release to warehouse date: (b)(4) 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020, that the patient underwent for an unknown surgery.During the surgery, the end of the cable cutter was wrapped off and cable did not cut.The surgery was completed successfully with 5 minutes delay.All fragments were removed without any additional intervention.There was no patient consequence.Concomitant devices reported: unknown cable (part#: unknown, lot#: unknown, quantity#: 1).This complaint involves one (1) device.This report is for (1) cable cutter.This is report 1 of 1 for (b)(4).

• Brand Name: CABLE CUTTER
• Common Device Name: CUTTER,WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10601108
• Report Number: 8030965-2020-07508
• Device Sequence Number: 3649821
• Product Code: HXZ
• UDI-Device Identifier: 07611819880313
• UDI-Public: (01)07611819880313
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: 03.607.513
• Device Lot Number: L874573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE