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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS ROD, FIXATION, INTRAMEDULLARY

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SYNTHES (USA) 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Catalog Number 04.005.416
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Due to the intra-operative events, the device was not successfully implanted. As such, implant/explant dates are not applicable. The subject device fragment is not expected to be returned to the synthes manufacturer for evaluation. 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. 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 during an initial multiloc humeral nailing procedure, the 4. 0mm locking screw was overtightened and the screw head broke off from the shaft. The screw head fragment was easily removed but the surgeon opted to leave the shaft of the screw in the patient's bone. The procedure was successfully completed without reported surgical delay or additional medical intervention. The patient's post-operative status was noted to be stable. This report is 1 of 1 for (b)(4).
 
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Brand Name4.0MM TI LOCKING SCREW W/T25 STARDRIVE 26MM FOR IM NAILS
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5900037
MDR Text Key52863829
Report Number2520274-2016-14336
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,health
Reporter Occupation
Type of Report Initial
Report Date 08/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.005.416
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 Received08/09/2016
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

Patient Treatment Data
Date Received: 08/24/2016 Patient Sequence Number: 1
Treatment
UNKNOWN T25 STARDRIVE SCREWDRIVER 26MM FOR IM NAIL
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