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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 Problems Break; Material Fragmentation
Event Date 02/18/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). Patient¿s year of birth was reported as 1943. (b)(4). Device is an instrument and is not implanted or explanted. The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. Device 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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that an 8. 5mm medullary reamer head broke during a surgical procedure on (b)(6) 2016. Device fragments were left in the patient. The procedure was completed without delay. This report is 1 of 1 for com-(b)(4).

 
Manufacturer Narrative

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

Additional information was received on february 25, 2016 reporting that the surgical procedure was performed to implant a nail to treat a tibial shaft fracture. The previously reported reamer head broke in the intramedullary canal and it was too difficult to remove all the fragments. The fragments remain in the patient's bone as previously reported.

 
Manufacturer Narrative

An empty package, shipped by the facility, was received on april 11, 2016. The device was reportedly lost during return shipment. As the complainant device was lost during return shipment, no evaluation can or will be conducted. Device 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.

 
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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 (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5486638
Report Number2520274-2016-11536
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/22/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/08/2016
Is This An Adverse Event Report? Yes
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2016
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

Patient TREATMENT DATA
Date Received: 03/08/2016 Patient Sequence Number: 1
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