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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL 10 R 125 L280 TIMO15 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA FEM NAIL 10 R 125 L280 TIMO15 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.018S
Device Problem Break (1069)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. 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 history lot, part # 04. 037. 018s, synthes lot # h849263, supplier lot # n/a, release to warehouse date: 15 mar 2019, expiration date: 01 mar 2029, manufacturing location: (b)(4), no ncr's were generated during production. Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition. 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
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 sub-trochanteric fracture of femur with the nail, the end cap, the locking screw and the screw in question. The surgery was completed successfully without any surgical delay. After the surgery, the patient had been able to walk with a cane with immediate full weight bearing. The patient was followed up on a monthly basis after discharge, and although bone contact was confirmed, callus bridging was not confirmed. On (b)(6) 2021, the patient visited the hospital complaining of pain while walking, and it was found that the nail opening was broken. On (b)(6) 2021, the patient underwent the revision surgery and the fractured nail was removed. The patient was revised with two rag fixes inserted into the bone head and the affected area was fixed again with a gamma 3 -120 °f12-170 mm and u lug screw 80 mm. The revision surgery was completed successfully without any surgical delay. The surgeon commented that stress concentration and accumulation of metal fatigue due to delayed bone union were thought to have led to implant fracture, and that patient-derived delayed bone union was the main cause of nail fracture since the patient had atypical fracture and 10 years of treatment for osteoporosis. No further information is available. This report is for one (1) tfna fem nail ø10 r 125° l280 timo15. This is report 1 of 4 for (b)(4).
 
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Brand NameTFNA FEM NAIL 10 R 125 L280 TIMO15
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12632479
MDR Text Key276401622
Report Number8030965-2021-08676
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.018S
Device Lot NumberH849263
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
Treatment
LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA SCR PERF L80 TAN
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