MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10 FULL THREAD, 2.7MM/L24MM; SCREW, FIXATION, BONE

Model Number 657024

Device Problems Material Fragmentation (1261); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

Foot injury.Extended surgery time.Chip formation.Screw change 4 x.Length of surgical delay is not reported.

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.Since the exact lot number of the device was not communicated, the sales record from the year 2018 to till date was reviewed and a total of 7 lots of locking screw, t10 full thread, 2.7mm/l24mm were identified which were delivered to the reported hospital.Those lots were reviewed for investigation purpose.A review of the device history for the 7 reported lots did not indicate any abnormalities.No deviation from the specifications was noted.No indications of material, manufacturing or design related problems were found during the investigation.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.

Event Description

Foot injury.Extended surgery time.Chip formation.Screw change 4 x.Length of surgical delay is not reported.

• Brand Name: LOCKING SCREW, T10 FULL THREAD, 2.7MM/L24MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10603214
• MDR Text Key: 209429101
• Report Number: 0008031020-2020-02279
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07613327069310
• UDI-Public: 07613327069310
• Combination Product (y/n): N
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657024
• Device Catalogue Number: 657024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR