MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L30MM; SCREW, FIXATION, BONE

Model Number 657430S

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.

Event 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.".

Manufacturer Narrative

The reported event could be confirmed based on the metal fragments received.However, since the screws were not returned, it was not possible to perform a proper inspection.It was also impossible to determine the root cause of the material fragmentation and to which screw each fragment belonged.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 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 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: BONE SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L30MM
• 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 Key: 16353068
• MDR Text Key: 309314579
• Report Number: 0008031020-2023-00084
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327074079
• UDI-Public: 07613327074079
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 657430S
• Device Catalogue Number: 657430S
• Device Lot Number: Y15502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 58 KG