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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TFNA SCR PERF L80 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH TFNA SCR PERF L80 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.180S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Additional procode: ktt. 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 number: 04. 038. 180s, lot number: 475p651, part manufacture date: 24-mar-2020, manufacturing location: (b)(4), part expiration date: 01-mar-2030, nonconformance noted: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of tfna fenestrated screw 80mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted. This lot was shipped from elmira to monument as part number 04. 038m180sp, lot number 45p6391, and assigned as part number 04. 038. 180s for final packaging. This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted. This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. Device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that 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 scr perf l80 tan. This is report 4 of 4 for (b)(4).
 
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Brand NameTFNA SCR PERF L80 TAN
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 Key12632787
MDR Text Key276404362
Report Number8030965-2021-08685
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? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number04.038.180S
Device Lot Number47P5651
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 Manufactured03/24/2020
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 FEM NAIL Ø10 R 125° L280 TIMO15
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