MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 20 HOLE / L415MM; PLATE, FIXATION, BONE

Catalog Number	627650S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/14/2019
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 customer reported that the patient was implanted with an axsos plate and screws approximately 1 year ago.The patient also had an expandable (non-stryker) plate implanted.This expandable plate stopped working, so the surgeon decided to revise and upon x-ray ((b)(6) 2019) he noticed that 3 axsos locking screws had backed out of the plate.The patient was revised because of the expandable plate, not the stryker locking screws.
Additional Manufacturer Narrative
Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
The customer reported that the patient was implanted with an axsos plate and screws approximately 1 year ago.The patient also had an expandable (non-stryker) plate implanted.This expandable plate stopped working, so the surgeon decided to revise and upon x-ray ((b)(6) 2019) he noticed that 3 axsos locking screws had backed out of the plate.The patient was revised because of the expandable plate, not the stryker locking screws.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 20 HOLE / L415MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8731036
• Report Number: 0008031020-2019-00728
• Device Sequence Number: 1807985
• Product Code: HRS
• UDI-Device Identifier: 07613327005295
• UDI-Public: 07613327005295
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K181091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627650S
• Device Lot Number: L04286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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