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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - REAMERS: REAMER HEAD REAMAR

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - REAMERS: REAMER HEAD REAMAR Back to Search Results
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 01/21/2020
Event Type  Injury  
Manufacturer Narrative

This report is for an unk - reamers: reamer head/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 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. (b)(4) used to capture: the reported event required medical/surgical intervention to preclude permanent damage to a body structure. 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 that on (b)(6) 2020, while the surgeon was using the reamer irrigator aspirator (ria) system for bone graft harvest from the right femur to repair a tibial non-union the tip of the ria drive shaft was broken, and the tip remained lodged in the ria reamer head. The surgeon measured the medullary canal during pre-operative scout x-rays and a 16. 5mm ria reamer head was chosen for the ria assembly based on a 16mm canal measurement. Ria was tested for proper connections and irrigation/aspiration before inserting it in the patient. He encountered difficulty before the reamer reached the isthmus and decided to change the ria head to 16mm. Upon 2nd pass, the reamer was unable to advance passed the isthmus again. After troubleshooting, it was found out that the aspiration was clogged and there wasn't any bone graft collected in the ria filter. At that point, everything was disassembled and was discovered that the tip of the ria drive shaft was broken. Ria shaft was changed and jumped up to a 17. 0mm ria reamer head since it was the only size left to choose from. No broken pieces remained in the patient. There was a 30 minutes surgical delay. The procedure was successfully completed. There was no patient consequence. This is report 03 of 04 of (b)(4).

 
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Brand NameUNK - REAMERS: REAMER HEAD
Type of DeviceREAMAR
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 Key9699643
MDR Text Key189205295
Report Number2939274-2020-00788
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received03/16/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 02/12/2020 Patient Sequence Number: 1
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