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

Additional narrative: the investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot, part: 392.000, lot: l616945, manufacturing site: bettlach, release to warehouse date: 05.Dec.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, there was an unknown piece of of the device stuck inside during use.No further information available.This report is for one (1) bending iron for 1.25mm, 1.6mm & 2.0mm kirschner wires this is report 1 of 1 for (b)(4).

• 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
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9166232
• MDR Text Key: 191575956
• Report Number: 8030965-2019-69135
• Device Sequence Number: 1
• Product Code: HXP
• UDI-Device Identifier: 07611819024847
• UDI-Public: (01)07611819024847
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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: L616945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• 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