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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: LOCKING; SCREW,FIXATION,BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: LOCKING; SCREW,FIXATION,BONE Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in (b)(4) as follows: it was reported that on (b)(6) 2019, distal radius osteosynthesis surgery was performed with the placement of distal radio plate.It was fixed by placing a locking screw in the lateral distal hole of the plate which did not allow the locking.The procedure was completed without complication.This report is for one (1) unk - screws: locking.This is report 2 of 2 for (b)(4).
 
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Brand Name
UNK - SCREWS: LOCKING
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key9611292
MDR Text Key190488856
Report Number2939274-2020-00299
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/27/2019
Initial Date FDA Received01/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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