MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BENDING IRON FOR 1.25MM, 1.6MM & 2.0MM KIRSCHNER WIRES; INSTR,BENDING OR CONTOURING

Catalog Number 392.000

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an unknown date an unknown k-wire was stuck inside the bending iron for kirschner wires.It was unknown if there were patient and procedure involvement.This report is for one (1) bending iron.This is report 1 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.Device evaluated by mfr: part: 392.000; lot: 2034; manufacturing site: bettlach.Dhr not available as device is older than 15 years.At this time, the manufacturing documents for instruments had to be stored for 10 years.This was according to specifications which were in place until august 2014.Product was not returned.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.

• Brand Name: BENDING IRON FOR 1.25MM, 1.6MM & 2.0MM KIRSCHNER WIRES
• Type of Device: INSTR,BENDING OR CONTOURING
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7967615
• MDR Text Key: 123947591
• Report Number: 8030965-2018-57354
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 07611819024847
• UDI-Public: (01)07611819024847
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 392.000
• Device Lot Number: 2034
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1