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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH RIA 2 BONE HARVESTING KIT 520MM STERILE REAMER

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SYNTHES GMBH RIA 2 BONE HARVESTING KIT 520MM STERILE REAMER Back to Search Results
Catalog Number 03.404.000S
Device Problems Break (1069); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2021
Event Type  Malfunction  
Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. The investigation could not be completed. No conclusion could be drawn, as no product was received. 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. 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 (b)(6) reports an event as follows: it was reported than on (b)(6) 2021 that there was a problem with the ria 2 equipment. The reaming rod seal crumpled around the drive shaft for ria2 and the reamer head would not attach to the drive shaft. Concomitant device: reamer head f/ria 2 ø13 (part 03. 404. 022s, lot 46p3569, quantity 1). This report is for one (1) ria 2 bone harvesting kit 520mm sterile. This is report 1 of 1 for (b)(4).

 
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Brand NameRIA 2 BONE HARVESTING KIT 520MM STERILE
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11294536
MDR Text Key245349362
Report Number8030965-2021-00880
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK111437
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/01/2021
Device Catalogue Number03.404.000S
Device LOT Number69P3536
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 Received04/07/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/24/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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