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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA BOLT, FIXATION, BONE

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SYNTHES USA BOLT, FIXATION, BONE Back to Search Results
Device Problem Bent (1059)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Harrington p. , et al (1996). Unreamed nailing of tibial fractures - a prospective study of the routine use of the unreamed tibial nail. Ijms, volume 165, no. 4, pp. 282-285. Republic of ireland this report is for unknown locking bolts, unknown quantity, unknown lot. Udi #: unknown part number, udi unavailable. The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part 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
This report is being filed after the subsequent review of the following literature article: harrington p. , et al (1996). Unreamed nailing of tibial fractures - a prospective study of the routine use of the unreamed tibial nail. Ijms, volume 165, no. 4, pp. 282-285. Republic of ireland. The purpose of the study was to evaluate the use and efficacy of the unreamed tibial nail (utn) in patients with varying types of tibial fractures. The study consisted of 44 patients (9 female and 35 male) and was conducted over a 24 month period, dates unknown. Complications reported included device breakage, malunion, revision surgery due to valgus malalignment, removal of a device, insertion point pain, compartment syndrome with foot drop requiring fasciotomy, incomplete traction palsy of the peroneal nerve, and one patient death. This is report 2 of 2 for (b)(4). This report is for unknown locking bolts. This is related to devices bending.
 
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Type of DeviceBOLT, FIXATION, BONE
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5430038
MDR Text Key37984650
Report Number2520274-2016-10721
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
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 01/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberUNKNOWN
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 Received01/19/2016
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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