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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 3.5MM TI LOCKING SCR SLF-TPNG ROD,FIXATION,INTRAMEDULLARY

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SYNTHES BETTLACH 3.5MM TI LOCKING SCR SLF-TPNG 3.5MM TI LOCKING SCR SLF-TPNG ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 412.111S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Device used for treatment, not diagnosis. (b)(4). The device broke postop and required an intervention to remove and replace the device. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates that the: manufacturing location: 412. 111s / 8588734; manufacturing location: (b)(4); manufacturing date: 05. Sep. 2013 expiry date: 01. Aug. 2023. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 on an event in (b)(6) as follows: it was reported that on (b)(6) 2016, the patient had surgery because she had suffered from valgus type degenerative ankle disease. After the surgery, the screws were broken because the patient ignored load restriction. Surgical revision is planned on (b)(6) 2017. The patient is in her fifties and has a delay in rehabilitation; the plate was revised but the screw shafts were left in patient. This complaint involves 3 parts. Concomitant medical products: 1x unk distal tibia 4 hole plate. This report is 3 of 3 for (b)(4).
 
Manufacturer Narrative
Additional device code used ktt. (b)(6). Manufacturing evaluation has been completed. The broken product was returned in a packaging different from the original packaging. Usage marks were visible on the returned product and in additional the broken tip was not delivered. All complaint relevant dimensions were measured, and fulfill the specifications. The raw material certificates were checked and it was found that all used raw material fulfilled the specifications. Based on this the complaint is rated as confirmed but not valid from the manufacturing point of view. No manufacturing related issue was identified and/or confirmed. 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 Name3.5MM TI LOCKING SCR SLF-TPNG 3.5MM TI LOCKING SCR SLF-TPNG
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 Key6378322
MDR Text Key69091938
Report Number9612488-2017-10090
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number412.111S
Device Lot Number8588734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2013
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: 03/03/2017 Patient Sequence Number: 1
Treatment
1X UNK DISTAL TIBIA 4 HOLE PLATE.
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