MAUDE Adverse Event Report: STRYKER GMBH RECTANGULAR PLATE, SIZE 1; PLATE, FIXATION, BONE

Model Number	40-15031S
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2020
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 remains implanted.
Event or Problem Description
As reported: "on (b)(6) 2020, back out of the locking screw which was implanted on (b)(6) 2020 was reveled.The surgeon has no view about the cause of the event.".
Event or Problem Description
As reported: "on (b)(6)-2020, back out of the locking screw which was implanted on (b)(6)-2020 was reveled.The surgeon has no view about the cause of the event." implants were removed.
Additional Manufacturer Narrative
Correction: sections b1, h1, h3 (reason code - other).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.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.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.However, the most probable cause or the failure would be but not limited to: insertion of screw in an angle greater than allowed leading to stripping of threads or cross threading with the plate, secondary complications in patients leading to loosening etc.If the device is returned or any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.

• Brand Name: RECTANGULAR PLATE, SIZE 1
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10457076
• Report Number: 0008031020-2020-02191
• Device Sequence Number: 11794592
• Product Code: HRS
• UDI-Device Identifier: 04546540538628
• UDI-Public: 04546540538628
• Combination Product (Y/N): N
• PMA/510(K) Number: K063875
• 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): 11/23/2020

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 Expiration Date: 02/29/2024
• Device Model Number: 40-15031S
• Device Catalogue Number: 40-15031S
• Device Lot Number: 1000349684
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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
• Patient Age: 60 YR