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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.037.060S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/05/2021
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a trochanteric fixation nail-advanced (tfna) procedure on (b)(6) 2021, after drilling with the stepped reamer a small crown shaped piece of metal was seen on x-ray in the femoral head. Surgeon was unable to remove it. The procedure was delayed by twenty (20) minutes. No further information was provided. This report is for one (1) 10mm/130 deg ti cann tfna 400mm/right - sterile. This is report 2 of 2 for complaint (b)(4).
 
Manufacturer Narrative
Part is not expected to be returned for manufacturer review/investigation. A device history record (dhr) review was conducted: manufacturing location: (b)(4), manufacturing date: 04-mar-2020, expiration date: 01-feb-2030, part number: 04. 037. 060s, 10mm/130 deg ti cann tfna 400mm / right ¿ sterile, lot number: 44p6050 (sterile) , lot quantity: (b)(4). Production order traveler met all inspection acceptance criteria. Inspection sheet, in process / inspect dimensional / final, met all inspection acceptance criteria. Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria. Packaging label log (pll) was reviewed and determined to be conforming. Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified. Scn was reviewed and determined to be conforming. 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. 3, tfna lock drive, lot number: 39p5140, lot quantity: (b)(4). Production order traveler met all inspection acceptance criteria. Inspection sheet met all inspection acceptance criteria. Part number: 04. 037. 912. 4, wave spring, shim ended, lot number: 21p6665, lot quantity: (b)(4). Production order traveler met all inspection acceptance criteria. Inspection sheet, incoming final inspection met all inspection acceptance criteria. Material certification and certificate of conformance and quality history card dated 09-jan-2020 were reviewed and determined to be conforming. Part number: 04. 037. 942. 2, lock prong, 130 degree, tfna, lot number: 25p9935, lot quantity: (b)(4). Production order traveler met all inspection acceptance criteria. Inspection sheet, final inspection, met all inspection acceptance criteria. Part number: 21127, timoagri16. 00, lot number: 26p7393, lot quantity: (b)(6) lbs. Inspection instruction met all inspection acceptance criteria. Certified test report dated 09-sep-2019 was reviewed and determined to be conforming. Lot summary report dated 19-nov-2019 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. 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.
 
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Brand Name10MM/130 DEG TI CANN TFNA 400MM/RIGHT - 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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12924423
MDR Text Key281678994
Report Number8030965-2021-09938
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
Report Date 11/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.037.060S
Device Lot Number44P6050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2020
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
Treatment
STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH
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