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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 ARTHROSCOPE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE ARTHROSCOPE Back to Search Results
Model Number 03.404.018S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
Product complaint (b)(4). Additional narrative: additional pro-code: hto. Complainant device is not expected to be returned for manufacturer review/investigation. A review of the device history records has been requested and is currently pending completion. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 an unknown date, during removal the reamer irrigator aspirator (ria) 2 reamer head broke off during reaming. The reamer was removed and fragments not retrievable. It was unknown if there was a surgical delay. The procedure was successfully completed. Patient outcome was unknown. This (b)(4) captures the intra-op event during removal, the reamer head broke off. (b)(4) captures the postop event, removal due to nonunion. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand Name11.0MM 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
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11798039
MDR Text Key249730334
Report Number2939274-2021-02276
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 Notification
Type of Report Initial,Followup,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
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 Number70P1935
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 Received10/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown
Removal/Correction NumberZ-0573-2021

Patient Treatment Data
Date Received: 05/10/2021 Patient Sequence Number: 1
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