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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM TI ANGULAR STABLE LCKNG SCR T25 30MM F/IM NAILS-STER ROD, FIXATION, INTRAMEDULLARY

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SYNTHES BETTLACH 5.0MM TI ANGULAR STABLE LCKNG SCR T25 30MM F/IM NAILS-STER ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.025.520S
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complainant part has not been explanted. The device is not expected to be returned for manufacturer review/investigation. Investigation could not be completed and no conclusion could be drawn as no device was returned. Device history record review: manufacturing site: (b)(4) - manufacturing date: march 15, 2010 - expiry date: march 1, 2015. No non-conformance reports were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device 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
It was reported that a post-operative review of paperwork was completed following an angular stable locking system (asls) tibial nailing procedure on (b)(6) 2016. During the review, it was discovered that a 5. 0mm asls screw had been implanted past its expiration date. The screw has not been removed. Concomitant device(s) reported: titanium cannulated tibial nail-ex (part: 04. 004. 546s / lot: unknown / quantity: 1). This report is 1 of 1 for (b)(4).
 
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Brand Name5.0MM TI ANGULAR STABLE LCKNG SCR T25 30MM F/IM NAILS-STER
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer (Section G)
SYNTHES BETTLACH
muracherstrasse 3
bettlach CH254 4
SZ CH2544
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5959792
MDR Text Key55033124
Report Number9612488-2016-10387
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090241
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2015
Device Catalogue Number04.025.520S
Device Lot Number2576051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2010
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: 09/19/2016 Patient Sequence Number: 1
Treatment
04.004.546S: 11MM TI CANNULATED TIBIAL NAIL-EX
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