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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA ROD, FIXATION, INTRAMEDULLARY

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SYNTHES USA ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problems Break (1069); Material Fragmentation (1261); Difficult to Remove (1528)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
(b)(6). The exact date of device breakage and non-union is unknown. This report is for one (1) unknown broken locking screw. At this time, the exact part number is unknown, but is likely one of the following three: 04. 005. 420: 4. 0mm ti locking screw w/t25 stardrive 30mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002, 04. 005. 424: 4. 0mm ti locking screw w/t25 stardrive 34mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002, 04. 005. 430: 4. 0mm ti locking screw w/t25 stardrive 40mm for im nails ¿ hsb: rod, fixation, intramedullary ¿ k103002. Without verification of the exact part number and its associated lot, the udi is not available. Per facility, the complainant part is not expected to be returned for manufacturing review/investigation. Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. 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.
 
Event Description
It was reported that a hardware removal and revision procedure was performed on (b)(6) 2016. The patient presented with non-union; it was then confirmed that one (1) of the implanted 4. 0mm titanium (ti) locking screws had broken distally. During the revision, a ti adolescent lateral femoral nail and three (3) screws were removed. A portion of the broken screw remained in situ. The patient was then revised with a proximal femur hook plate. The procedure was completed successfully with a post-operative patient outcome of stable. Concomitant device(s) reported: femoral nail (part: 04. 031. 934s / lot: unknown / quantity: 1), recon screw (part: 04. 031. 025 or 04. 031. 028 / lot: unknown / quantity: 1), locking screws (partial part: 04. 005. 4xx / lot: unknown / quantity: 2). This report is for one (1) unknown broken ti locking screw. This report is 1 of 1 for com-(b)(4).
 
Manufacturer Narrative
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 the non-union and broken screw were discovered on an unknown date via an x-ray.
 
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Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES USA
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5857216
MDR Text Key51495969
Report Number2520274-2016-13989
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,Followup
Report Date 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? Yes
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 Received08/25/2016
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: 08/09/2016 Patient Sequence Number: 1
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