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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - PLATES: FNS PLATE,FIXATION,BONE Back to Search Results
Catalog Number UNK - PLATES: FNS
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for neck fracture of femur. After the fns was inserted, the surgeon tried to apply inter-fragmentary compression intraoperatively, but the compression could not be applied because the silver cylinder of the insert came off and the black ring also loosened. Therefore, the surgeon gave up the compression and tried to remove the device by completely loosening the black ring, but the device did not come off the implant. When the black ring was kept turned, it came off, and all instruments were disassembled and could be removed from the implant. When the sales rep later checked the device, it was found that the device, which should not have been disassembled, had been disassembled. The surgery was completed successfully with a thirty (30) minute delay. No further information is available. This report is for one (1) unknown plate this is report 3 of 3 for (b)(4).
 
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown plate/unknown lot. Part and lot numbers are unknown; udi number is unknown. 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. 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 NameUNK - PLATES: FNS
Type of DevicePLATE,FIXATION,BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13252976
MDR Text Key287708960
Report Number8030965-2022-00314
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 Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK - PLATES: FNS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/13/2022 Patient Sequence Number: 1
Treatment
INS F/INSERTION HANDLE; MULTIFUNCTION ROD F/INSERTION INSTR
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