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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM FLEXIBLE SHAFT REAMER

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SYNTHES GMBH 5.0MM FLEXIBLE SHAFT REAMER Back to Search Results
Catalog Number 352.040
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2020
Event Type  Malfunction  
Manufacturer Narrative

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. 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the surgery for femoral trochanteric fracture. During the surgery, the surgeon couldn¿t connect the reamer head to the shaft firmly. The reamer head was easy to come off from the shaft. The surgeon applied the force to connect them and they were connected successfully. The surgery was completed successfully within thirty (30) minutes delay. Patient outcome is reported as stable. No further information is available. This report is for one (1) 5. 0mm flexible shaft this is report 1 of 1 for complaint (b)(4).

 
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Brand Name5.0MM FLEXIBLE SHAFT
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10996061
MDR Text Key234501026
Report Number8030965-2020-09645
Device Sequence Number1
Product Code HTO
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 11/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
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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