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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SAGITTAL SAW ATTACHMENT, LONG, FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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SYNTHES GMBH SAGITTAL SAW ATTACHMENT, LONG, FOR TRS INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 05.001.224
Device Problems Noise, Audible (3273); Excessive Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
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. The initial reporter's phone number was not available. 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 from hungary that during post-surgery, it was discovered that the attachment device made a strange noise and overheated. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in (b)(6) 2021. 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 NameSAGITTAL SAW ATTACHMENT, LONG, FOR TRS
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/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 Key12479562
MDR Text Key271656489
Report Number8030965-2021-07773
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeHU
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,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number05.001.224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2019
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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