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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA REAMER

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SYNTHES USA REAMER Back to Search Results
Device Problem Device Operates Differently Than Expected
Event Date 11/19/2015
Event Type  Injury  
Manufacturer Narrative

Patient initials: (b)(6). Patient weight not available for reporting. Pma 510(k): report is for one (1) one unknown reamer shaft. Other: udi: unknown part number; unknown lot number; udi unknown. Implant and explant dates: device is an instrument and is not implanted/explanted. (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. Mfg date: unknown. 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 while the surgeon was reaming, the reamer head became stuck in the medullary canal. The physician attempted to reverse the drill and the reamer shaft came apart. A ball tip reaming rod was used to remove the parts without difficulty. There was a surgical delay of five (5) minutes. The surgery was successfully completed without further incident. This report is for one (1) one unknown reamer shaft. This is report 2 of 2 for (b)(4).

 
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Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5285918
Report Number2520274-2015-17774
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 11/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2015
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2015
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? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/10/2015 Patient Sequence Number: 1
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