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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE Back to Search Results
Model Number 03.404.016S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2020, patient underwent a procedure the ria reamer malfunction with intramedullary nail breakage causing a couple of retained metal fragments. Device broke when the tip was attached between the reamer head and the shaft. It would have caused more problems to try to remove the fragments since what was placed was a large titanium tibial nail. Concomitant devices reported: unk - screws: trauma(part# unknown, lot# unknown, qty unknown); unk - nails: tibial(part# unknown, lot# unknown, qty 1). This report is for one (1) 10. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. 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. 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 Name10.0MM REAMER HEAD FOR RIA 2 STERILE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12923729
MDR Text Key281662705
Report Number2939274-2021-06940
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.404.016S
Device Catalogue Number03.404.016S
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
Treatment
UNK - NAILS: TIBIAL; UNK - SCREWS: TRAUMA
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