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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.5MM MEDULLARY REAMER HEAD

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.5MM MEDULLARY REAMER HEAD Back to Search Results
Catalog Number 352.085
Device Problems Break; Material Fragmentation
Event Date 09/01/2018
Event Type  Injury  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Patient id: (b)(6). Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. The investigation could not be completed; no conclusion could be drawn. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis.

 
Event Description

It was reported that during orthopedic procedure on (b)(6) 2018, while doing a long left trochanteric femoral nail (tfn), the surgeon stopped reaming while he was in the isthmus, the hardest part of the bone. When he restarted the reamer, he heard a pop and noted by fluoro that the 8. 5mm end cutting reamer head had broken. The head and reamer shaft were removed but one small piece of the reamer head was irretrievable. The reaming guide wire was removed, and the intact part of the reamer head came out with it as designed. A new guide wire was positioned, and the case continued. There was a minimal surgical delay. Procedure was completed successfully. This complaint involves one (1) device. This is report 1 of 1 for (b)(4).

 
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Brand Name8.5MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ  2545
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7974303
Report Number2939274-2018-54423
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/17/2018
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 Received09/26/2018
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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