MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V2 - LEFT; PLATE, FIXATION, BONE

Model Number	PLP11341
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/07/2020
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
The pharmacist at the hospital reported the following event : "on (b)(6) 2019, the patient had an arthrodesis at the big toe performed as follows: 1 fixos 4.0 screw + one 5-hole anchorage plate, 5 valgus screws: 10°- dorsal flexion: 20 °.On (b)(6) 2020, the patient presented a premature rupture of his plate, probably in connection with mechanical stresses and underwent a revision surgery to remove the devices with additional bone grafting and implantation of a larger plate and more compression screws.".
Additional Manufacturer Narrative
Due to the current covid-19 pandemic, it was not possible to inspect the product as the access to the facility is restricted.Moreover, to fully investigate the case, the x-rays are needed.However, due to the current restrictions, the x-rays cannot be provided.The investigation will be reassessed as soon as the restriction is lifted.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The pharmacist at the hospital reported the following event : "on (b)(6) 2019, the patient had an arthrodesis at the big toe performed [.] as follows : 1 fixos 4.0 screw + one 5-hole anchorage plate, 5 valgus screws: 10°- dorsal flexion: 20 °.On (b)(6) 2020, the patient presented a premature rupture of his plate, probably in connection with mechanical stresses and underwent a revision surgery to remove the devices with additional bone grafting and implantation of a larger plate and more compression screws.".

• Brand Name: PLATE ANCHORAGE MTP / VERSION V2 - LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9789449
• Report Number: 0008031020-2020-00581
• Device Sequence Number: 2456445
• Product Code: HRS
• UDI-Device Identifier: 07613252260493
• UDI-Public: 07613252260493
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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: PLP11341
• Device Catalogue Number: PLP11341
• Device Lot Number: Y23577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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