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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH AO REAMING ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

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SYNTHES GMBH AO REAMING ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT Back to Search Results
Catalog Number 05.001.210
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
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.Additional narrative: reporter¿s phone number is not available.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was received fallen apart.The cylindric pin was missing which is crucial for the subassembly¿s function.The long hole from output shaft was showing a small dent.It was determined that the device became damaged when it was twisted, and it should not have been reassembled after initial failure.It was also found that the device failed pre-test for general condition and check the tool coupling.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to the user, which is user error.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.Udi: (b)(4).Please reference report mwr-24062021-0000985604 as it is related to this medwatch report.
 
Event Description
It was reported from (b)(6) that during an open reduction internal fixation (orif) surgery for fracture of the proximal femur, when removing a reaming device from the attachment device, the connection of the attachment and a reaming device had come loose because the operation staff slightly twisted the device.It was further reported that the device was twisted back and was able to be used, and the procedure was successfully completed.It was reported that the next day, during cleaning of the device it became loose again, and the parts of the attachment were disassembled into 6 pieces and could not be assembled.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no 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.
 
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Brand Name
AO REAMING ATTACHMENT FOR TRS
Type of Device
INSTRUMENT, 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 Key12378758
MDR Text Key268513249
Report Number8030965-2021-07294
Device Sequence Number1
Product Code HWE
UDI-Device Identifier07611819977891
UDI-Public07611819977891
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 company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2021
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 Catalogue Number05.001.210
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2021
Initial Date Manufacturer Received 08/17/2021
Initial Date FDA Received08/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2018
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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