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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL 12 125 L200 TI ROD, FIXATION, INTRAMEDULLARY

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SYNTHES GMBH TFNA FEM NAIL 12 125 L200 TI ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.037.213S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: product complaint # (b)(4). 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. Device history lot: part # 04. 037. 213s. Lot # h048836. Manufacturing site: werk selzach. Release to warehouse date: 2 mar 2016. Expiration date: 1 mar 2026. A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified. 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.
 
Event Description
It was reported that on (b)(6), 2021, the patient underwent the open reduction internal fixation with the tfna for the fracture of the trochanteric femur. The surgery was completed successfully without any surgical delay. However, the pseudarthrosis has occurred, and there was a possibility that the implant will break, or cut-out will occur, so that the surgeon will remove the tfna and perform the bipolar hip arthroplasty on (b)(6), 2022. According to the surgeon, the pseudarthrosis occurred because the femoral bone head was fixed with an outward bow and a gap in the calcar part. The surgeon had a poor impression with synthes product since the case of malfunctions continue. No further information is available. This complaint involves only four(4) devices.
 
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Brand NameTFNA FEM NAIL 12 125 L200 TI
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13830437
MDR Text Key287556679
Report Number8030965-2022-01755
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 Other,Foreign,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 Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.037.213S
Device Lot NumberH048836
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2016
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/20/2022 Patient Sequence Number: 1
Treatment
LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL 12 125 L200 T; TFNA HELICAL BLADE PERF L80 TAN
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