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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/34MM-STER ROD, FIXATION, INTRAMEDULLARY

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SYNTHES BETTLACH 3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/34MM-STER ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 412.113S
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Date of implant is not known. Complainant part is not expected to be returned for manufacturer review/investigation. Concomitant device therapy date is not known. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 (b)(4) reports an event in (b)(6) as follows: it was reported patient was implanted on unknown date with a locking compression plate (lcp) medial proximal tibia plate and unknown quantity of screws. Patient was returned to surgery on (b)(6) 2017 for a planned removal of the implants. During the removal procedure, it was noted that the 3. 5mm locking screw that had been fixed on the proximal side of the plate had broken around the screw head. Surgeon noted the screw broke post-operatively and not during removal. It was further noted that some fragments from the broken screw may have been left in the patient. Surgery was completed successfully, patient bone is reported as healed and patient status reported as good. Concomitant devices reported: lcp medial proximal tibia plate (part 439. 956s, lot number unknown, quantity 1) this report is for one (1) 3. 5mm titanium locking screw this is report 1 of 1 for (b)(4).
 
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Brand Name3.5MM TI LOCKING SCR SLF-TPNG W/STARDRIVE RECESS/34MM-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
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6755140
MDR Text Key81507954
Report Number9612488-2017-10375
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103002
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 07/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number412.113S
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 Received07/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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