MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SMALL WIRE CUTTER 160MM; CUTTER,WIRE

Catalog Number 391.900

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

Device used in a veterinary case - no patient information will be reported.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 synthes reports an event in (b)(6) as follows: veterinary complaint: it was reported that on (b)(6) 2019, the pair of pin cutters were used about three (3) times where the edge was noted to separate.The issue was found during inspection.There was no patient or procedure involvement.This report is for one (1) small wire cutter 160mm.This is report 1 of 1 for (b)(4).

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.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.Concomitant medical products: device was returned for evaluation.Review of the picture has shown that the cutting plate is broken off.The manufacturing documents were reviewed and no complaint related issues were found.Product was not returned, therefore no further investigation possible and no root cause can be defined.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information or material is made available, the investigation will be updated as applicable.,investigation site: cq zuchwil selected flow: damaged: visual | examples: deformed/bent/cracked/broken the visual inspection has shown that almost the complete cutting plate is broken off at one of the jaws.The fragment was returned for evaluation.On the other side is a clearly visible nick at the cutting plate.The breakage occurred at the weld between the stainless steel body and the stellite cutting plate.Due to the weld residues the relevant dimensions cannot be verified anymore.The complaint is confirmed as one cutting plate is broken off as complained.The review of the manufacturing documents has shown that the device was made according to the specification.This lot of 32 pieces was manufactured in april 2018 and we are not aware of any other complaint for this article- and lot number combination.The inspection of the fracture face with a 10x magnifier did show that the weld was applied homogeneous.No manufacturing related issue could be identified.Based on the provided information the cause of the breakage cannot be defined.The clearly visible nick at the still attached cutting plate could be an indication for a mechanical overload during use.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.Part number: 391.900.Lot number: t157474.Manufacturing site: tuttlingen.Release to warehouse date: 26-apr-2018.A review of the device history records was performed for the finished device lot number, and an nc nr-0071672 was started because the laser marking was incomplete.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The devices were reworked and the final quality release criteria were met before this batch was released for distribution.The nc have no impact on the complaint issue.The raw material certificate was reviewed and the used material was according to the specification of the device.,was performed in pi-(b)(6).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Review of the picture has shown that the cutting plate is broken off.The manufacturing documents were reviewed and no complaint related issues were found.Product was not returned, therefore no further investigation possible and no root cause can be defined.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information or material is made available, the investigation will be updated as applicable.Device history lot part number: 391.900 lot number: t157474 manufacturing site: tuttlingen release to warehouse date: 26-apr-2018 a review of the device history records was performed for the finished device lot number.The laser marking was incomplete.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The devices were reworked and the final quality release criteria were met before this batch was released for distribution.The nc have no impact on the complaint issue.The raw material certificate was reviewed and the used material was according to the specification of the device.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: SMALL WIRE CUTTER 160MM
• Type of Device: CUTTER,WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8478730
• MDR Text Key: 140894700
• Report Number: 8030965-2019-62460
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024762
• UDI-Public: (01)07611819024762
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.900
• Device Lot Number: T157474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1