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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BURR ATTACHMENT-LONG FOR PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES GMBH BURR ATTACHMENT-LONG FOR PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.047
Device Problems Noise, Audible (3273); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Event Description
It was reported from (b)(6) that the attachment device had a noise and heating problem. It was not reported if the event occurred during a surgical procedure. It was not reported if there was a delay to a planned procedure. It was not reported if there was a spare device available for use. There was no patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate. Reporter's phone number was not provided. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. Udi ¿ (b)(4).
 
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Brand NameBURR ATTACHMENT-LONG FOR PEN DRIVE
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
MDR Report Key12557841
MDR Text Key281392637
Report Number8030965-2021-08194
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.047
Device Lot Number3L31103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No

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