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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - CABLE/WIRE: TRAUMA; WIRE, SURGICAL

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SYNTHES GMBH UNK - CABLE/WIRE: TRAUMA; WIRE, SURGICAL Back to Search Results
Device Problems Break (1069); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2023
Event Type  malfunction  
Event Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent the unknown surgery with va clavicle.As temporary fixation, the surgeon used compression wires in question in the locking holes.When attempting to remove the compression wire after screw insertion, he mistakenly used a power tool to remove it in a forward rotation, causing the compression wire to break off from the base of the ball of the wire.Despite attempts to remove it, he was unable to grasp it.The assistant senior surgeon determined that there was no problem with the compression wire being implanted, and the surgery was completed with the wire in place.Regarding the cause of the breakage, the surgeon believes that the compression wire was broken because he tried to pull it out forcibly in an oblique direction instead of straight up.No further information is available.This report is for an unk - cable/wire: trauma.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.This report is for an unknown cable/wire: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthese employee.Without a lot number the device history records review could not be completed.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.
 
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Brand Name
UNK - CABLE/WIRE: TRAUMA
Type of Device
WIRE, SURGICAL
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key16436364
MDR Text Key310334210
Report Number8030965-2023-02288
Device Sequence Number1
Product Code LRN
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2023
Initial Date FDA Received02/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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