• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW ROD,FIXATION,INTRAMEDULLARY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.026
Device Problem Sticking (1597)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Dhr review was completed. Manufacturing location: (b)(4), release to warehouse date: 20. Apr. 2015. 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. 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.
 
Manufacturer Narrative
Customer quality conducted an investigation of the returned devices: tfna screw inserter (03. 037. 025) and coupling screw (03. 037. 026) it was observed that the proximal cannulation was slightly deformed. Additionally, the distal cannulation was observed to be deformed and there is evidence of impact to this end of the device. The balance of the device has typical wear which does not impact functionality. There is no indication that the device is bent. The coupling screw was observed to be slightly bent in the distal section of the device. There is evidence of wear on the proximal end of the device which appears to be related to interaction with the deformed screw inserter. The coupling screw becomes stuck to the screw inserter when mating the devices. The coupling screw cannot be fully inserted. The deformation of the proximal cannulation of the screw inserter can be observed while the coupling screw is partially inserted. The complaint regarding deformation and the devices being stuck is confirmed. The devices becoming stuck was able to be replicated. Dhr review for each of the devices 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. The material and relevant material properties were determined to be conforming for the device lots based on review of the dhr. The following drawings were reviewed during investigation. Connecting screw for blade/srew. The diameter of the distal end of the coupling screw (03. 037. 026) measured 5. 93mm which is within the specification of 6. 0mm + 0. 0 /- 0. 1. The diameter of the proximal end of the coupling screw measured 12. 29mm which is within specification of 12. 3mm +/- 0. 02. No definitive root cause was able to be determined. The conditions experienced by the devices is unknown however it appears that the devices experienced excessive forces which were not in line with the intended use. 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.
 
Manufacturer Narrative
Device used for treatment, not diagnosis. No patient involvement reported. Other udi: (b)(4) lot number unknown. Udi unavailable. Device is an instrument and is not implanted/explanted. Date returned to manufacturer. 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. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. 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 the sales consultant noticed a damaged proximal femoral nailing system (tfna) instrumentation. The sales consultant is not sure if the issue occurred during a case or post-operatively. He said that most likely it occurred post-operatively. He further stated there are four devices that appear to be severely bent. In his opinion, something heavy might have dropped down on the instruments, that may have caused them to be bent. He also said that the four devices are stuck together. There is no other concomitant part involved. There is no patient or procedure involved. This complaint involves three (3) devices. This report is 3 of 3 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHELICAL BLADE/SCREW COUPLING SCREW
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 Key6919723
MDR Text Key254268476
Report Number9612488-2017-10509
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.026
Device Lot Number9461705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-