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

Model Number 657312

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "a (b)(6)-year-old female pt underwent the clavicle joint surgery (left) on (b)(6) 2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6) 2020.".

Manufacturer Narrative

Corrections: please refer to sections d2a, d2b, d4 (catalog number), gtin number, g4 (510(k)) and h6 (device code).The reported event could be confirmed based on the x-ray image provided.The device inspection revealed the following: the received locking screw observed with damaged threads.The threads were found damaged in a tearing fashion around the edges.The damage around the upper thread suggests loosening initiated from this region which resulted in release of bending tension from the plate and resulting in loosening of near screw from the hole & bone.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation and the available information, the root cause was attributed to a patient related issue.The failure was most likely caused due to screws not able to gain purchase at the location where they were placed which resulted in separation of screws from the plate.Considering the age of the patient & opinion from the sr, failure mode is more attributable to patient related (weak bone quality, patient activity etc.).If any further information is provided, the complaint report will be updated.

Event Description

As reported: "a 90-year-old female pt underwent the clavicle joint surgery (left) on (b)(6)2020.After the operation, the plate moved and the screw came off the plate, and the revision surgery was performed on (b)(6)-2020".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10887908
• MDR Text Key: 217973397
• Report Number: 0008031020-2020-02492
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086812
• UDI-Public: 07613327086812
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 657312
• Device Catalogue Number: 657312S
• Device Lot Number: G27493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR