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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) 8.5MM MEDULLARY REAMER HEAD

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SYNTHES (USA) 8.5MM MEDULLARY REAMER HEAD Back to Search Results
Catalog Number 352.085
Device Problem Material Fragmentation
Event Date 07/30/2016
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Patient height is (b)(6). Patient initials are (b)(6). (b)(4). Device is an instrument and is not implanted/explanted. The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the user facility. 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. 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 during a tibia nail procedure on (b)(6) 2016 to repair a left tibia fracture, upon removal of the reamer head and shaft after the initial reaming pass it was noted that both items were chipped and not functional. A back-up shaft and reamer head were readily available and used to complete the procedure successfully with no further harm to patient. Surgery was delayed approximately three (3) minutes while the back-up set was prepared. No fragments were left behind in the patient as confirmed by x-ray. This report is 2 of 2 for (b)(4).

 
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Brand Name8.5MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5877714
Report Number2520274-2016-14103
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 07/30/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.085
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 Received07/30/2016
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

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