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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH NUT-KNURLED F/LARGE-DISTRACT APPARATUS, TRACTION, NON-POWERED

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SYNTHES GMBH NUT-KNURLED F/LARGE-DISTRACT APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 394.42
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in colombia as follows: it was reported on (b)(6) 2022 that the nut was blocked in the threaded bar, it did not cause a negative impact on the patient or the procedure. There is no further information. This report is for one (1) nut-knurled f/large-distract. This is report 2 of 2 for complaint (b)(4).
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Postal code (b)(6). 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.
 
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Brand NameNUT-KNURLED F/LARGE-DISTRACT
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 
SZ  
6103142063
MDR Report Key15129235
MDR Text Key298061124
Report Number8030965-2022-05397
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number394.42
Device Lot Number54P5457
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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