MAUDE Adverse Event Report: STRYKER GMBH BROAD STRAIGHT PLATE, 6 HOLES (T10) VARIAX2 FOOT; PLATE, FIXATION, BONE

Model Number	626976
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not accessible; still implanted in the patient.
Event or Problem Description
A patient (who pointed out she is an rn) said that she had a titanium implant placed in her great toe last october and it is now cracked.She assumes this will need a revision surgery.She would like to know how a titanium implant cracked.Update-phone call with patient (b)(6) 2021 patient went in for a follow up on (b)(6) 2021 and her physician found a crack in the titanium plate on her left great toe.A cartiva implant was removed to put in a stryker implant.Patient indicated that she called and left a voice mail for the cartiva complaint but had not heard back from anybody.Patient was non-weight bearing for three months post operatively.The patient would like to know why this happened.The patient has been using a bone stimulator since the operation and her physician advised she continue to use it for an additional four week to assess if there is additional damage to the bone or the bone stability.Her physician would determine at this four-week mark if a revision is needed.Update 5/21/2021 phone call with patient, she indicated that a revision of the device might happen.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A patient (who pointed out she is an rn) said that she had a titanium implant placed in her great toe last october and it is now cracked.She assumes this will need a revision surgery.She would like to know how a titanium implant cracked.Update-phone call with patient (b)(6)2021 patient went in for a follow up on (b)(6)2021 and her physician found a crack in the titanium plate on her left great toe.A cartiva implant was removed to put in a stryker implant.Patient indicated that she called and left a voice mail for the cartiva complaint but had not heard back from anybody.Patient was non-weight bearing for three months post operatively.The patient would like to know why this happened.The patient has been using a bone stimulator since the operation and her physician advised she continue to use it for an additional four week to assess if there is additional damage to the bone or the bone stability.Her physician would determine at this four-week mark if a revision is needed.Update (b)(6)2021 phone call with patient, she indicated that a revision of the device might happen.

• Brand Name: BROAD STRAIGHT PLATE, 6 HOLES (T10) VARIAX2 FOOT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11894987
• Report Number: 0008031020-2021-00245
• Device Sequence Number: 17052201
• Product Code: HRS
• UDI-Device Identifier: 07613327170887
• UDI-Public: 07613327170887
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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 Model Number: 626976
• Device Catalogue Number: 626976
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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
• Patient Age: 64 YR
• Patient Weight: 120