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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TRAUMA; PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: TRAUMA; PLATE, FIXATION, BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown plates: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the removal surgery of the tomofix plate for the proximal tibia.During the surgery, the surgeon could not remove the screws with the screwdriver.The surgeon replaced the handle with a t-handle which belonged to the hospital and tried to remove the screws, but the head of the screws stripped.The surgeon used the extraction screw; however, the tip of the extraction screw broke.The surgeon was able to remove the screws by chipping the head of the screws with the carbide drill and cut off from the plate.The surgery was completed successfully within 30 minutes delay.No fragments remain in the patient.The patient was reported as stable.This report involves one (1) unknown plates: trauma.This is report 4 of 4 for (b)(4).
 
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Brand Name
UNK - PLATES: TRAUMA
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13552428
MDR Text Key291614192
Report Number8030965-2022-00972
Device Sequence Number1
Product Code HRS
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 Physician
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 01/19/2022
Initial Date FDA Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
EXTRACT-SCREW CONI F/SCR Ø4.5+6.5; SCRDRIVERSHAFT-3.5-HEX SELF-HOLD; UNK - SCREWS: TRAUMA
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