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U.S. Department of Health and Human Services

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

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SYNTHES BETTLACH HELICAL BLADE/SCREW COUPLING SCREW ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 03.037.026
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/28/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). Device is an instrument and is not implanted/explanted. Manufacturing site: (b)(4). Manufacturing date: april 20, 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. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
It was reported that the surgeon was compressing the fracture on the patient's right side during open reduction internal fixation (orif) procedure using a trochanteric fixation nail advance (tfna) implants. While surgeon was doing the final tightening of the lag screw, the tip of the helical blade coupling screw instrument broke off inside of the lag screw. The tip portion of the helical blade coupling screw instrument was left inside the lag screw that was implanted in the patient. Surgery was delayed an additional five (5) minutes due to the reported malfunction. Patient was reported in stable condition. Concomitant devices reported: fixation nail (part 04. 037. 042, lot unknown, quantity 1); screw inserter (part 03. 038. 025, lot unknown, quantity 1). This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
An investigation summary was performed. The investigation of the complaint articles has shown that: one helical blade/screw coupling screw (part number 03. 037. 026, lot number 9461705) was received with the complaint category of ¿broken: tip broken intra-operatively. ¿ it was reported that the surgeon was compressing the fracture on the patient's right side during open reduction internal fixation (orif) procedure using a trochanteric fixation nail advance (tfna) implants. While surgeon was doing the final tightening of the lag screw, the tip of the helical blade and screw coupling screw instrument broke off inside of the lag screw. The tip portion of the helical blade and screw coupling screw instrument was left inside the lag screw that was implanted in the patient. Surgery was delayed an additional 5 minutes due to the reported malfunction. Patient was reported in stable condition. Based on the returned device it is estimated that approximately 8mm +/-3 is missing from the distal tip. Impact marts consistent with use were observed on the proximal surface of the device. However, slight impact marks inconsistent with recommended use were observed on the underside of the proximal end of the device. Deformation of the proximal threads was also observed. The balance of the device shows wear and is in functional condition. Thus, the complaint condition is confirmed and consistent with the reported condition. Replication of the complaint condition is not applicable as the device is already broken. The break sustained by the coupling screw is consistent with exposure to force beyond the yield limit of the material, possibly due to incomplete engagement of the helical blade or screw and/or off axis application of force. However, given the unknown circumstances at the time of the break a root cause cannot be definitively determined. 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.
 
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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
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5893288
MDR Text Key52638403
Report Number9612488-2016-10341
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
Report Date 07/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.037.026
Device Lot Number9461705
Other Device ID Number(01)10886982070425(10)9461705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
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

Patient Treatment Data
Date Received: 08/22/2016 Patient Sequence Number: 1
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