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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA QUARTER-TUBULAR PLATE WITH COLLAR 5 HOLES/39MM; APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT

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SYNTHES USA QUARTER-TUBULAR PLATE WITH COLLAR 5 HOLES/39MM; APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT Back to Search Results
Catalog Number 242.05
Device Problem Break (1069)
Patient Problems Pain (1994); Impaired Healing (2378)
Event Type  Injury  
Manufacturer Narrative
(b)(4).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
It was reported that a male patient had a hardware removal with revision of a right second metatarsal on (b)(6) 2016.The original open reduction internal fixation (orif) was performed on (b)(6), 2015.The patient subsequently complained of pain and x-rays revealed a broken plate and fracture nonunion.The broken 2.7mm tubular plate and four (4) fully intact cortical screws were explanted.A new 2.7mm tubular plate and four new cortical screws were implanted.The procedure was completed successfully with no harm to the patient.The plate was discarded.(b)(4).
 
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Brand Name
QUARTER-TUBULAR PLATE WITH COLLAR 5 HOLES/39MM
Type of Device
APPLIANCE, FIXATION, NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
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 Key5381068
MDR Text Key36437728
Report Number2520274-2016-10358
Device Sequence Number1
Product Code KTW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK010321
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number242.05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/07/2016
Initial Date FDA Received01/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
4 UNKNOWN CORTICAL SCREWS
Patient Outcome(s) Required Intervention;
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