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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 15.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 15.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC Back to Search Results
Model Number 03.404.026S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/15/2021
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. Device history review - this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.
 
Event Description
It was reported that on (b)(6) 2021, there was a tibial shaft non-union of the ria 2 on femur during a bone grafting. The reaming rod was placed into one of the condyles of the distal femur, while reaming over there was a slight bent. The reamer head broke off onto the reaming rod and the times that hold the reamer head to the tube assembly were broken off into the patient. Reaming rod was then pulled out and the tube assembly was not damaged. We were able to add a new reaming head and continue reaming. The surgeon said he does ria 1 over bend all the time so he was surprised when it broke off. Also told me that he was going slow and was not forcing it over the slight curve in the reaming rod. Tiny pieces of ria 2 head left inside the patient. Concomitant device reported: unk - reaming rods: (part# unknown; lot# unknown; quantity: tibial shaft unknown). Unk - reamers (part# unknown; lot# unknown; quantity: unknown). This report is for one (1) 15. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand Name15.0MM 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11815698
MDR Text Key262619259
Report Number2939274-2021-02349
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.404.026S
Device Catalogue Number03.404.026S
Device Lot Number79P8469
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 Received06/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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