MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH WIRE CUTTER 220MM; CUTTER, WIRE

Catalog Number 391.930

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted: part number: 391.930; synthes lot number: t135588; release to warehouse date: 05-jan-2017; manufacture site: (b)(4); part expiration date: n/a; list of nonconformance¿s: n/a.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The raw material certificate was reviewed and the used material was according to the specification of the device.No ncrs were generated during the production of this device.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 product investigation was conducted.Visual inspection: upon visual inspection of the complaint device it can be seen that on the tip section the cutting edges are badly damaged and some bits are chipped off, this thus confirming the complaint description.Furthermore, three (3) of four (4) welding point are broken.Otherwise, the article is in good but well used condition.Functional test: a functional test was performed per 100% (with a 0.6mm and a 2.0mm kirschner wires) at the time of manufacturing with no non-conformities documented.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Material or hardness review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no material or hardness review is needed.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place, or/and that wrong and/or not allowed material got cut, led to this damage.To prevent such problems, it is necessary worn or damaged instruments to replace and/or to operate according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: it was reported that, the teeth of two (2) large wirecutters were chipped during an unknown surgery on (b)(6) 2019.Another wirecutter was used to complete the procedure.There was no reported surgical delay.Patient outcome is unknown.This report is for one (1) wire cutter 220mm.This is report 2 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: upon visual inspection of the complaint device it can be seen that on the tip section the cutting edges are badly damaged and some bits are chipped off, this thus confirming the complaint description.Furthermore, three (3) of four (4) welding point are broken.Otherwise, the article is in good but well used condition.Document/specification review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Material or hardness review: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no material or hardness review is needed.Summary: there is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place, or/and that wrong and/or not allowed material got cut, led to this damage.To prevent such problems, it is necessary worn or damaged instruments to replace and/or to operate according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot part number: 391.930 synthes lot number: t135588 release to warehouse date: 05-jan-2017 manufacture site: tuttlingen part expiration date: n/a list of nonconformance¿s: n/a a review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The raw material certificate was reviewed and the used material was according to the specification of the device.No ncrs were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.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: WIRE CUTTER 220MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8292926
• MDR Text Key: 134703563
• Report Number: 8030965-2019-60527
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024779
• UDI-Public: (01)07611819024779
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.930
• Device Lot Number: T135588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1