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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH HUDSON DRILLING ATTACHMENT F/BPL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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SYNTHES GMBH HUDSON DRILLING ATTACHMENT F/BPL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 530.792
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
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. The 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).
 
Event Description
It was reported that during an unspecified surgical procedure, it was discovered that the hudson drilling attachment device came apart. It was not reported if there were any delays in the surgical procedure or if a spare device was available for use. There was patient involvement reported. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand NameHUDSON DRILLING ATTACHMENT F/BPL
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES PRODUKTIONS GMBH
hauptstrasse 24
waldenburg 4437
SZ 4437
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key12685125
MDR Text Key278126290
Report Number8030965-2021-08892
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number530.792
Device Lot Number8901479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2014
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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