MAUDE Adverse Event Report: STRYKER GMBH LATERAL COLUMN LENGTHENING PLATE VARIAX 2 FOOT L: 0MM, T10; PLATE, FIXATION, BONE

Model Number	626800
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported: consultation at the beginning of march for fracture of plate implanted in november 2022 with pseudarthrosis.Explantation and revision of the fracture with a va-lcp 2.7mm palmar plate.Update received on 27 mar 2023 from customer: plates broke after the procedure.Patient had pain.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition unknown.
Event or Problem Description
Customer reported: consultation at the beginning on (b)(6) for fracture of plate implanted on (b)(6) 2022 with pseudarthrosis.Explantation and revision of the fracture with a va-lcp 2.7mm palmar plate.Update received on (b)(6) 2023 from customer: plates broke after the procedure.Patient had pain.

• Brand Name: LATERAL COLUMN LENGTHENING PLATE VARIAX 2 FOOT L: 0MM, T10
• Common Device Name: PLATE, 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: 16773396
• Report Number: 0008031020-2023-00143
• Device Sequence Number: 6397425
• Product Code: HRS
• UDI-Device Identifier: 07613327125504
• UDI-Public: 07613327125504
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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 Model Number: 626800
• Device Catalogue Number: 626800
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown