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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 340MM/LEFT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 340MM/LEFT-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.255S
Device Problem Break (1069)
Patient Problem Non-union Bone Fracture (2369)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Manufacturing location: (b)(4), manufacturing date: 14-jun-2019, expiration date: 01-jun-2029, part number: 04. 037. 255s, 12mm/130 deg ti cann tfna 340mm/leftt- sterile, lot number: 3l44982 (sterile), lot quantity: 6. One piece was scrapped for a cannulation runout failure. The remainder of the lot was 100% inspected for this feature and determined to be conforming. Production order traveler met all inspection acceptance criteria apart from the one piece noted. Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria apart from the one piece noted. Inspection sheet, tfna assembly inspection met all inspection acceptance criteria. Packaging label log (pll) lmd was reviewed and determined to be conforming. Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Component part(s) reviewed: part number: 04. 037. 912. 4, wave spring, shim ended. Lot number: h761689, lot quantity: 1,000. Work order traveler met all inspection acceptance criteria. Inspection sheet, incoming final inspection met all inspection acceptance criteria. Material certificate and certificate of conformance and quality history card were reviewed and determined to be conforming. Part number: 04. 037. 942. 2, lock prong, 130 degree tfna, lot number: 4l55694, lot quantity: 95. Production order traveler met all inspection acceptance criteria. Part number: 04. 037. 912. 3, tfna lock drive , lot number: h869544, lot quantity: 139. Production order traveler met all inspection acceptance criteria. Inspection sheet, met all inspection acceptance criteria. Part number: 21127, timoagri16. 00, lot number: h870510, lot quantity: 3,430 lbs. Certificate of test was reviewed and determined to be conforming. Lot summary report met all inspection acceptance criteria. Raw material receiving / putaway checklist met all inspection acceptance criteria. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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 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 an unknown date, the patients nail broke post-operatively. The patient suffers from cancer and the fracture will not heal. The broken nail was removed. Another nail and proximal femoral plate were implanted. The revision surgery was completed successfully. This report involves one (1) 12mm/130 deg ti cann tfna 340mm/left-sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name12MM/130 DEG TI CANN TFNA 340MM/LEFT-STERILE
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 Key12569275
MDR Text Key274526669
Report Number8030965-2021-08330
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.255S
Device Lot Number3L44982
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2019
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/04/2021 Patient Sequence Number: 1
Treatment
UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
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