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

Catalog Number 03.607.513

Device Problem Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2020

Event Type  malfunction  

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 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
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10601108
• MDR Text Key: 209012738
• Report Number: 8030965-2020-07508
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819880313
• UDI-Public: (01)07611819880313
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - CABLE/WIRE