MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L55MM; SCREW, FIXATION, BONE

Model Number	657355S
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: metal fragments were observed when a non-locking screw was inserted in the oval hole and a locking screw in the round hole, respectively.Only the metal fragments were retrieved.The locking screw did not lock upon insertion and was spinning all the time.
Additional Manufacturer Narrative
The reported event could not be confirmed.Only the material fragmentation could be confirmed, based on the fragments returned.However, since the screws were not returned, it was not possible to perform a proper inspection and to determine the root cause of the material fragmentation.It was also impossible the determine to which screw each fragment belonged.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.
Event or Problem Description
As reported: "event1: metal fragments were observed when a non-locking screw was inserted in the oval hole and a locking screw in the round hole, respectively.Only the metal fragments were retrieved.Event2: the locking screw did not lock upon insertion and was spinning all the time.".

• Brand Name: LOCKING SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L55MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16353077
• Report Number: 0008031020-2023-00083
• Device Sequence Number: 12468555
• Product Code: HWC
• UDI-Device Identifier: 07613327087413
• UDI-Public: 07613327087413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• 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): 03/21/2023

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 Expiration Date: 04/30/2024
• Device Model Number: 657355S
• Device Catalogue Number: 657355S
• Device Lot Number: D26778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2019
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 58 KG