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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number UNK - NAIL HEAD ELEMENTS: FNS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
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. Brand name, common device name, manufacturer name, city and state, lot #, pma/510k: this report is for an unknown device/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter coccupation: reporter is a j&j sales representative. Lot #, mfr site, device manufacture date: the lot number was unknown. Therefore, the expiration date and device manufacture date were unknown. Device evaluated by mfr and manufacturer date: without a lot number the device history records review could not be completed. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and 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.
 
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 3 of 4 for (b)(4). It was reported by the sales rep in japan that a patient underwent an open reduction internal fixation surgery with the fns devices for the fracture of the femoral neck on (b)(6) 2022. It was reported that the surgery was completed successfully without any surgical delay. However, after the surgery, the patient complained of pain; and the examination confirmed that an internal deformity of the bone head had occurred. The revision surgery with removing the fns and the bipolar hip arthroplasty was reported to be performed. No additional information was provided. This complaint involves four (4) devices.
 
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Brand NameUNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14518109
MDR Text Key293266846
Report Number8030965-2022-03556
Device Sequence Number1
Product Code HSB
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,User Facility,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 Received05/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - NAIL HEAD ELEMENTS: FNS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/26/2022 Patient Sequence Number: 1
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