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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC REAMER

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WRIGHTS LANE : SYNTHES USA PRODUCTS LLC REAMER Back to Search Results
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/19/2016
Event Type  Injury  
Manufacturer Narrative

Additional narrative: patient information not available for reporting. 510k: this report is for an unknown reamer/unknown lot. Part and lot numbers are unknown; udi number is unknown. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. 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 a reamer head disconnected from the reamer shaft on a flexible reamer without a ball tip reaming rod. The broken fragment remained lodged in patient¿s femoral canal during a total hip procedure on (b)(6) 2017. Surgeon attempted to retrieve the fragment. It is not known if the fragment was retrieved or if it remains embedded in patient¿s bone. This report is for one (1) unknown reamer. (b)(4).

 
Manufacturer Narrative

Without a lot number the device history records review could not be completed. 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 during an anterior hip arthroplasty procedure on (b)(6) 2017, the reamer head came off of the reamer shaft while surgeon was reaming the canal. It was noted a ball tip guide wire was not used during the reaming process. Surgeon was not able to retrieve the reamer head from the femoral canal and it remains in the patient. Surgery was delayed approximately 30 minutes while attempting to retrieve the reamer head.

 
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Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key7192004
MDR Text Key97293466
Report Number2939274-2018-50271
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 HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2018
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 Received01/24/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 01/15/2018 Patient Sequence Number: 1
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