MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA, 8 HOLE / L108MM; PLATE, FIXATION, BONE

Catalog Number	4020808S
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/19/2019
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
It was reported that the patient was undergoing orif surgery with variax fibula plate for fracture of the ulna at (b)(6) 2019.After that, the plate was broken and revision surgery was done at (b)(6) 2019.The patient had mental illness and the surgeon guessed that she hit the surgical area against the wall many times and broke it.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned plate is indeed broken as reported.The surfaces of the broken plate indicate a sudden sidewise movement from the patient (unknown incident).That led to the belief that the patient may have indeed caused the breakage due to an uncontrolled incident as she is mentally ill, as reported by the customer.The close up views, indicating though that the surface of the breakage is homogenous which again indicate conformity to the given specification.The returned screws are still intact and only show very minimal traces due to the removal (concomitant items).Based on investigation, the root cause was attributed to be patient related.The failure was caused by actions of the patient, based on the reported event.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 investigation report will be updated.
Event or Problem Description
It was reported that the patient was undergoing orif surgery with variax fibula plate for fracture of the ulna at 2019/jun/14.After that, the plate was broken and revision surgery was done at 2019/jun/21.The patient had mental illness and the surgeon guessed that she hit the surgical area against the wall many times and broke it.

• Brand Name: STRAIGHT PLATE VARIAX FIBULA, 8 HOLE / L108MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8784647
• Report Number: 0008031020-2019-00830
• Device Sequence Number: 19343602
• Product Code: HRS
• UDI-Device Identifier: 04546540667816
• UDI-Public: 04546540667816
• Combination Product (Y/N): N
• PMA/510(K) Number: K102282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 4020808S
• Device Lot Number: Y45749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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