MAUDE Adverse Event Report: STRYKER GMBH CURVED PLATE, 4 HOLES; PLATE, FIXATION, BONE

Catalog Number	40-15011
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	07/20/2018
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
Patient's husband called stating his wife had a left foot surgery done on (b)(6) 2017.Husband stated mris showed the plate broken in half, the plate was removed on (b)(6) 2018.During removal of plate the surgeon noticed the bone was healing incorrectly, therefore patient was not implanted with another plate.
Additional Manufacturer Narrative
The reported event could be confirmed.More detailed information about the complaint event (x-rays and patient's activity level) 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.Device disposition unknown.
Event or Problem Description
Patient's husband called stating his wife had a left foot surgery done on (b)(6) 2017.Husband stated mris showed the plate broken in half, the plate was removed on (b)(6) 2018.During removal of plate the surgeon noticed the bone was healing incorrectly, therefore patient was not implanted with another plate.

• Brand Name: CURVED PLATE, 4 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8631411
• Report Number: 0008031020-2019-00510
• Device Sequence Number: 13938572
• Product Code: HRS
• UDI-Device Identifier: 07613154627783
• UDI-Public: 07613154627783
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 40-15011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/05/2019
• 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: 63 YR