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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN MICRO ASNIS 3MM; SCREW, FIXATION, BONE
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STRYKER GMBH UNKNOWN MICRO ASNIS 3MM; SCREW, FIXATION, BONE Back to Search Results
Catalog Number UNK_SEL
Device Problems Break (1069); Fracture (1260); Difficult to Remove (1528)
Patient Problem Insufficient Information (4580)
Event Date 09/28/2022
Event Type  malfunction  
Event Description
As reported: "micro asnis 3mm screw removal surgery.The screw to be removed during surgery broke.The surgeons own removal chisel was used in the removal surgery, but was not suitable for the base.The screw was very tight." it is unclear if debris was left in the patient.
 
Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
 
Manufacturer Narrative
Please note the correction to h6 component code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were 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 was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
 
Event Description
As reported: "micro asnis 3mm screw removal surgery.The screw to be removed during surgery broke.The surgeons own removal chisel was used in the removal surgery, but was not suitable for the base.The screw was very tight." it is unclear if debris was left in the patient.
 
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Brand Name
UNKNOWN MICRO ASNIS 3MM
Type of Device
SCREW, 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
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key15712571
MDR Text Key307168786
Report Number0008031020-2022-00566
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2022
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
Patient Sequence Number1
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