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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES GMBH QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 532.022
Device Problems Material Fragmentation (1261); Device-Device Incompatibility (2919); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2022
Event Type  malfunction  
Event Description
It was reported from canada that during an unspecified surgical procedure it was observed that the quick coupling device was making a very strange, loud sound when being operated, and the device was not retaining the k-wire. It was reported that the device was emitting metal pieces almost like frying the wire. It was reported that there was a 15-minute delay in the procedure due to the event. It was reported that an unspecified spare device was available. It was unknown if the procedure was successfully completed. 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. Concomitant med products and therapy dates: k-wire device (23mar2022) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. (b)(4).
 
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Brand NameQUICK COUPLING FOR K-WIRES
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key13904976
MDR Text Key296750208
Report Number8030965-2022-01938
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819107199
UDI-Public07611819107199
Combination Product (y/n)N
Reporter Country CodeCA
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
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number532.022
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2016
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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