MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; SCREW, FIXATION, BONE

Model Number	657312
Medical Device Problem Codes	Positioning Failure (1158); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "surgeon was using the variax 2 small frag and variax 2 core tray for an ankle fracture.The surgeon used proper technique in regards to using the drill sleeve and stayed within the 30 degree cone that the 40-20905 fibula plate warrants.Upon inserting a 657016 locking screw, it did not engage the locking mechanism.The surgeon removed the screw and used a fresh/ new 657016 screw in the same screw hole and the screw engaged the plate and locking was successful.Later on in the case, he attempted to engage (3) 657312 locking screws into the same 40-20905 plate with the same appropriate technique and those screws also did not engage/lock into the plate successfully and there was also metal shavings that appeared after the removal of the screws.The metal shavings are not known if they came from the screws or the fibula plate".
Event or Problem Description
As reported: "surgeon was using the variax 2 small frag and variax 2 core tray for an ankle fracture.The surgeon used proper technique in regards to using the drill sleeve and stayed within the 30 degree cone that the 40-20905 fibula plate warrants.Upon inserting a 657016 locking screw, it did not engage the locking mechanism.The surgeon removed the screw and used a fresh/ new 657016 screw in the same screw hole and the screw engaged the plate and locking was successful.Later on in the case, he attempted to engage (3) 657312 locking screws into the same 40-20905 plate with the same appropriate technique and those screws also did not engage/lock into the plate successfully and there was also metal shavings that appeared after the removal of the screws.The metal shavings are not known if they came from the screws or the fibula plate".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A potential non-conformity report was initiated to address similar events in the past.The comprehensive root cause analysis of the potential ncr included a surface and microstructure analysis as well as nano-indent hardness measurement of variax1 and variax2 screw samples by the fraunhofer institute on behalf of stryker.Further internal investigation efforts were focusing on the anodization color difference between variax1 and variax2 screws.Significant differences between the screws which could result in the reported complaints have not been revealed in either fraunhofer or stryker investigations.Excessive in-house handling and bench testing with variax2 screws from various manufacturing batches showed that locking is achieved as intended.The desired increase in torque indicating to the customer that the screw is locking in the plate, can be confirmed.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Considering the information given and based on the above investigations a root cause of the reported event could not be determined.If any further substantial information is provided, the investigation report will be updated.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11670078
• Report Number: 0008031020-2021-00153
• Device Sequence Number: 16906522
• Product Code: HWC
• UDI-Device Identifier: 07613327086812
• UDI-Public: 07613327086812
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 657312
• Device Catalogue Number: 657312
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR