MAUDE Adverse Event Report: STRYKER GMBH 2.0MM, ASNIS MICRO, CANNULATED SCREW, 14/6MM, STERILE; SCREW, FIXATION, BONE

Catalog Number	40-20114S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains in the patient.
Event or Problem Description
During asnis removal surgery, the screw head deformed when using a screwdriver and the screw was unable to be removed from the patient's bone.The surgery was finished without the screw removal.Failed to remove the screw.
Event or Problem Description
During asnis removal surgery, the screw head deformed when using a screwdriver and the screw was unable to be removed from the patient's bone.The surgery was finished without the screw removal.Failed to remove the screw.
Additional Manufacturer Narrative
The reported event that 2.0mm, asnis micro, cannulated screw, 14/6mm, sterile was alleged of 'component/device stuck' could be confirmed (consulting the x-ray).Based on the given x-ray, the root cause was attributed to be user related.The failure was caused by too much mechanical force during the removal attempt.It is only visible on the x-ray that the screw had been left in situ.And it was mentioned that no damages were observed on the screwdriver.A review of the device history for the reported lot did not indicate any abnormalities.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.

• Brand Name: 2.0MM, ASNIS MICRO, CANNULATED SCREW, 14/6MM, STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7924066
• Report Number: 0008031020-2018-00698
• Device Sequence Number: 1449597
• Product Code: HWC
• UDI-Device Identifier: 04546540533296
• UDI-Public: 04546540533296
• Combination Product (Y/N): N
• PMA/510(K) Number: K071092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: 40-20114S
• Device Lot Number: 1000225076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR