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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number 03.404.018S
Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/12/2020
Event Type  Injury  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
Event Description
It was reported that on (b)(6) 2020 the patient underwent an orthopedic procedure. The surgeon performed a bone graft harvest from the left femur to bone graft a left humeral shaft non-union. The surgeon removed a 12 hole 4. 5 lc-dcp broad plate and twelve (12) cortex screws from the non-union site and then used the ria 2 system on the left femur to harvest bone graft. A reamer head for reamer irrigator aspirator (ria 2) was selected based on the measurement of the patient's femoral shaft. The surgeon entered the reamer head into the femoral canal and resistance occurred in the proximal third femoral canal. The surgeon retracted the reamer head and then advanced it several times and on the last retraction noticed the reamer head had come off of the drive shaft for reamer irrigator aspirator (ria 2). The doctor was able to retrieve the reamer head and noticed that three fragments from the reamer head had broken off. The surgeon was able to retrieve two of the fragments, but one fragment remained in the soft tissue. Once the two fragments were removed he used the ria system with a 12mm head to complete the bone harvest. The surgeon then implanted a 12 hole 4. 5 lcp broad plate and the harvested bone graft to the humerus. The drive shaft was difficult to remove from the tube assembly after the ria 2 was used. The reaming rod seal was noticed to be cracked. The procedure was successfully completed with a sixty (60) minute surgical delay. There was patient consequence. This report is for one (1) 11. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name11.0MM REAMER HEAD FOR RIA 2 STERILE
Type of DeviceACCESSORIES, ARTHROSCOPIC
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10189989
MDR Text Key196416610
Report Number2939274-2020-02968
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.404.018S
Device Catalogue Number03.404.018S
Device Lot Number43P7412
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 Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2020
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: 06/24/2020 Patient Sequence Number: 1
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