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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L70MM PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L70MM PLATE, FIXATION, BONE Back to Search Results
Model Number 661070
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
Event Description
As reported: "4. 0 x 70 mm screw stripped when trying to be backed out. ".
 
Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. A review of the device history was not possible because the lot number was not communicated. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation. If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
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Brand NameLOCKING SCREW AXSOS 3 TI 4.0MM / L70MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
SZ 2545
Manufacturer Contact
marilyne chaumont
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13282530
MDR Text Key283964221
Report Number0008031020-2022-00021
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123964
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number661070
Device Catalogue Number661070
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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