MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø6.5X40MM TL20MM; SCREW, FIXATION, BONE

Model Number	602640S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "when the screw was removed, we tried to manually remove it by counter-rotation with a screwdriver, but the screw was buried.The back of the lower leg was expanded, and the screw was finally removed with a screwdriver while countering the screw tip with forceps." the procedure was delayed by 20 min.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Additional Manufacturer Narrative
Correction: please refer to d4 lot number.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 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.
Event or Problem Description
As reported: "when the screw was removed, we tried to manually remove it by counter-rotation with a screwdriver, but the screw was buried.The back of the lower leg was expanded, and the screw was finally removed with a screwdriver while countering the screw tip with forceps." the procedure was delayed by 20 min.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø6.5X40MM TL20MM
• Common Device Name: 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13281706
• Report Number: 0008031020-2022-00020
• Device Sequence Number: 12056468
• Product Code: HWC
• UDI-Device Identifier: 04546540087638
• UDI-Public: 04546540087638
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: Health Professional
• Device Model Number: 602640S
• Device Catalogue Number: 602640S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown