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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SHORT CUT PLATE CUTTER INSTRUMENT, CUTTING, ORTHOPAEDIC
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE SHORT CUT PLATE CUTTER INSTRUMENT, CUTTING, ORTHOPAEDIC Back to Search Results
Model Number 03.503.057
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery. During the surgery, plate- benders both are break off simultaneously while trying to bend a plate. It was unknown if the surgery completed successfully. There was no fragment generated. There was no patient consequence. Concomitant device reported: unk - plates: (part# unknown; lot# unknown; quantity: unknown). This complaint involves (1) device. This report is for (1) matrixmandible short cut plate cutter. This report is 1 of 2 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4). Event year is reported as 2021; however exact date of event is unknown. Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. Telephone # (b)(6). Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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.
 
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Brand NameMATRIXMANDIBLE SHORT CUT PLATE CUTTER
Type of DeviceINSTRUMENT, CUTTING, ORTHOPAEDIC
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK HÄGENDORF (CH)
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13167916
MDR Text Key283241118
Report Number2939274-2022-00010
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.503.057
Device Catalogue Number03.503.057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2008
Is the Device Single Use? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
Treatment
MATRIXMANDIBLE SHORT CUT PLATE CUTTER; UNK - PLATES: TRAUMA
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