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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) 5.0MM FLEXIBLE SHAFT REAMER

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SYNTHES (USA) 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Material Fragmentation
Event Date 07/30/2016
Event Type  Malfunction  
Manufacturer Narrative

Patient height is (b)(6). Patient initials are (b)(6). (b)(4). Lot number unknown. 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 minutes while the back-up set was prepared. No fragments were left behind in the patient as confirmed by x-ray. This report is 1 of 2 for (b)(6).

 
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Brand Name5.0MM FLEXIBLE SHAFT
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 Key5877713
Report Number2520274-2016-14102
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 Number352.040
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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