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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.000S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Type  Injury  
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.
 
Manufacturer Narrative
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. 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. 038. 000s. Lot # 99p2954. Manufacturing site: (b)(4). Release to warehouse date: 23 april 2021. Expiry date: 01 april 2031. A manufacturing record. Evaluation was performed for the finished device lot and no non-conformance was identified. 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 NameTFNA END CAP EXTENS. 0 TAN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13830573
MDR Text Key287557094
Report Number8030965-2022-01758
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 Number04.038.000S
Device Lot Number99P2954
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 Manufactured04/23/2021
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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