MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM; PLATE, FIXATION, BONE

Model Number	657414
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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.".
Additional 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 bone screw observed with damaged threads.The threads were found damaged in a tearing fashion.The damage was caused due to tension on the plate followed by loosening of locking screw at the end which ultimately created a tension on plate resulting in loosening of the bone screw as well.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 or Problem 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: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10884977
• Report Number: 0008031020-2020-02490
• Device Sequence Number: 3511363
• Product Code: HRS
• UDI-Device Identifier: 07613327073782
• UDI-Public: 07613327073782
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2024
• Device Model Number: 657414
• Device Catalogue Number: 657414S
• Device Lot Number: D59325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention