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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE REAMER

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SYNTHES MONUMENT 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE REAMER Back to Search Results
Catalog Number 351.706S
Device Problems Break; Material Fragmentation
Event Date 09/21/2016
Event Type  Malfunction  
Manufacturer Narrative

There was no known reported patient involvement associated with the complained event. (b)(4). Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Device history record review for part 351. 706s, lot # h105332 revealed that no non conformance reports (ncr¿s) were generated during production. Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 prior to a case, a resident was evaluating some instruments and got a little aggressive while bending a reaming rod and it snapped into two (2) pieces. Fragments were generated. There was no patient or procedure involvement. Additional reaming rods were available for use. This is report 1 of 1 for (b)(4).

 
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Brand Name2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
mark vornheder
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key6016695
Report Number1719045-2016-10748
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 09/21/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number351.706S
Device LOT NumberH105332
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 Received09/21/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/16/2016
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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