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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL
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OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL Back to Search Results
Catalog Number 292.620S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
Additional procode: hty.Complainant part is not expected to be returned for manufacturer review/investigation.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 the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2019, the guide wire 1.25mm threaded tip w/trocar snapped inside the patient¿s tibia when being used to position a 3.5mm cannulated screw.There was no patient injury.Concomitant devices: 3.5mm cannulated screw (part: unknown, lot: unknown, quantity: 1) this report is for a 1.25mm threaded guide wire 150mm.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.A device history record (dhr) review was conducted: part: 292.620s.Lot: 4l16743.Manufacturing site: selzach.Supplier: frueh verpackungstechnik ag.Release to warehouse date: 05.Apr.2019.Expiry date: 01.Apr.2029.Device was first manufactured unsterile under the lot 4l02111 in balsthal and sterilized afterwards.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 292.620 with lot 4l02111 were reviewed: a manufacturing record evaluation was performed for the finished device lot number 4l02111, 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.
 
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.
 
Event Description
It was reported the procedure was successfully completed.
 
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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
MDR Report Key8873592
MDR Text Key153669032
Report Number8030965-2019-66993
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819733121
UDI-Public(01)07611819733121
Combination Product (y/n)N
PMA/PMN Number
PREAMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.620S
Device Lot Number4L16743
Was Device Available for Evaluation? No
Date Manufacturer Received09/13/2019
Patient Sequence Number1
Treatment
UNK - SCREWS: 3.5 MM CANNULATED; UNK - SCREWS: 3.5 MM CANNULATED
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