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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL

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SYNTHES USA 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL Back to Search Results
Catalog Number 292.620
Device Problem Break (1069)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 05/02/2016
Event Type  Injury  
Manufacturer Narrative
Device was used for treatment, not diagnosis.(b)(4).Device broke intraoperative not implanted of explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 that during an osteosynthesis for left bimalleolar fracture, two threaded steel wires for cannulated screws broke off.A broken off piece remained in the patients left tibia.This complaint involves 2 parts.This report is 2 of 2 for (b)(4).
 
Manufacturer Narrative
(b)(6).Device 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
Update 22sep2016: the parts of the guide wires are inside the patient's bone, the remaining parts have been discarded.Unknown if there was no patient harm, except or the piece left in the patient.Unknown if procedure was successfully completed.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.Serious injury determined on (b)(6) 2016 corrected data: x-rays were taken but not available for investigation review.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
1.25MM THREADED GUIDE WIRE 150MM
Type of Device
WIRE,SURGICAL
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5958267
MDR Text Key54997146
Report Number2520274-2016-14570
Device Sequence Number1
Product Code LRN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 09/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.620
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/13/2016
Initial Date FDA Received09/16/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received10/12/2016
11/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age30 YR
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