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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: TIBIA PLATE,FIXATION,BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: TIBIA PLATE,FIXATION,BONE Back to Search Results
Device Problem Component Missing (2306)
Patient Problems Injury (2348); No Code Available (3191)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Only event year is known. This report is for an unknown plates: tibia /unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review /investigation. Reporter is a synthes employee. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/ or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). 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)(6) as follows: it was reported that on an unknown date, that during an unknown procedure that the surgeon did not have the correct implants. The surgeon received a 3. 5 system for the proximal tibia, in which the longest plate was sixteen (16) holes. Prior to starting the procedure, the surgeon said it was fine to use the 3. 5 system. The patient was anesthetized but the skin was not incised. The surgeon externally measured the plate and realized the 3. 5 system could not be used. The surgeon stated that he requested the 30 cm plate, which was in the 4. 5 system. The patient received a cast. This report involves one (1) unknown plates: tibia. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - PLATES: TIBIA
Type of DevicePLATE,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 Key10471275
MDR Text Key204917048
Report Number2939274-2020-03869
Device Sequence Number1
Product Code HRS
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2020
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: 08/31/2020 Patient Sequence Number: 1
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