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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

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SYNTHES GMBH BATTERY OSCILLATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number 530.710
Device Problems Device Slipped (1584); Vibration (1674); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2023
Event Type  malfunction  
Event Description
It was reported from japan that during an unspecified surgical procedure it was observed that when the battery oscillator device was being used it had vibration.It was reported that the vibration caused the locking knob to turn and the blade lock to disengage.It was reported that the locking knob was fixed using oif tape and the device was used continuously.It was reported that there was no delay in the procedure due to the event.It was not reported if a spare device was available for use.There was 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
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: e1: reporter's phone number was not provided.D4: udi: lot/serial unknown.(b)(4).H4 device manufacture date: the device manufacture date is unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
 
Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the battery oscillator device and the reported condition that the device had vibration causing the locking knob to turn and the blade lock to disengage was confirmed.The device was visually inspected as received and it was found that the device failed the visual inspection due to being received with a detached turn knob.The device was fully functioning and reached the required speed requirements.It was further determined that the device failed pretest for general condition and check the quick coupling for saw blades.It was determined that the most relevant root cause could be linked to a design error.Further investigation and assessment are covered under a capa.Review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.
 
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Brand Name
BATTERY OSCILLATOR II FOR BPL II
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK PT & C (CH)
Manufacturer Contact
kate karberg
eimattstrasse 3
oberdorf 4436
SZ   4436
3035526892
MDR Report Key16727321
MDR Text Key313167989
Report Number8030965-2023-04539
Device Sequence Number1
Product Code GEY
UDI-Device Identifier07611819491847
UDI-Public07611819491847
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number530.710
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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