MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL

Catalog Number 292.62

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

Additional product code: hty.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: t was reported on (b)(6) 2020, that the patient underwent an unknown surgery.During the surgery, a kirchner got stuck in the drill bit after use and the user did not report it.It was unknown if the surgery was completed or delay.There was no fragment generation reported.There was no patient consequence.This complaint involves one (1) device.This report is for (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10372971
• MDR Text Key: 201867203
• Report Number: 8030965-2020-05676
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1