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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH FIBULINK; WASHER, BOLT NUT

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SYNTHES GMBH FIBULINK; WASHER, BOLT NUT Back to Search Results
Model Number FGS-1000
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/27/2021
Event Type  malfunction  
Event Description
While drilling the patient¿s bone, the tip of the drill bit broke while it was still inside the bone.Surgeon decided to leave the broken tip inside, according to him it would have caused more harm to retrieve it and it is not harmful to leave it inside the patient¿s bone.Surgeon decided to look at post op x-rays to determine the size of broken piece.Manufacturer response for implants (screw, drill bit, depuy synthes (per site reporter).The vendor rep has been informed of the incident, they will report the event to their company.
 
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Brand Name
FIBULINK
Type of Device
WASHER, BOLT NUT
Manufacturer (Section D)
SYNTHES GMBH
1302 wrights lane e
west chester PA 19380
MDR Report Key12744443
MDR Text Key279863264
Report Number12744443
Device Sequence Number1
Product Code HTN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFGS-1000
Device Catalogue NumberFGS1000
Device Lot Number21E018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2021
Event Location Hospital
Date Report to Manufacturer11/03/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age19345 DA
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