MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM; PLATE, FIXATION, BONE

Model Number 40-20807

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Limb Fracture (4518); Implant Pain (4561)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "initial procedure is (b)(6) 2020.Implanted plate.Lag screw 18mm for proximal and distal pieces.2 fiber wires used for 3rd bone piece.18 mm non-locking in the elliptical hole, and locking screws are used for all other holes.Postoperative rehabilitation: 4 weeks unloaded, 6 weeks full weight.The patient complained a pain on (b)(6) 2021.Proximal locking rupture + plate deflection were occurred on (b)(6) 2021.Broken the plate were occurred on (b)(6) 2021.The patient underwent a revision surgery.".

Event Description

As reported: "initial procedure is 2020(b)(6).Implanted plate.Lag screw 18mm for proximal and distal pieces.2 fiber wires used for 3rd bone piece.18 mm non-locking in the elliptical hole, and locking screws are used for all other holes.Postoperative rehabilitation: 4 weeks unloaded, 6 weeks full weight.The patient complained a pain on on 2021(b)(6).Proximal locking rupture + plate deflection were occurred on 2021(b)(6).Broken the plate were occurred on 2021/09/07.The patient underwent a revision surgery.".

Manufacturer Narrative

Please note corrections to section d4 catalog number and gtin.The reported event could be confirmed, since the plate is broken as complained.The device inspection revealed the following: the visual inspection has shown that the plate is broken apart next to the oblong hole.The breakage can also be confirmed on the received x-rays, the plate is displaced and in contact at the place of fracture.There are strong deformations on one side of the fracture faces visible, these deformations indicate a strong contact between the fragments after the breakage.Also the rest of the fracture face is shiny and abraded as the fragments rubbed against each other after the breakage causing destruction of the fracture surfaces.Due to this destruction no further evaluation of the facture face is possible.A dimensional inspection of the received plate was made and it can be confirmed that the relevant dimensions are within the specification.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.The complaint was forwarded to medical affairs to get a medical opinion with following feedback: a hypertrophic non-union can be seen on the follow up x-rays.The continuous pain reported by the patient is suggestive for the non-union as well.Especially the triangular wedge fragment is isolated from the blood supply of the bone and this leads to an increased risk of non-union.The young age of the patient contributed to the high amount of bone stock around the fracture zone, but due to the continuous movements in the fracture line no consolidation occurred.The non-union resulted in an overload of the plate followed by the plate breakage.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by a non-union which resulted in an overload of the plate and the screws followed by breakage of the devices.If more information is provided, the case will be reassessed.

• Brand Name: STRAIGHT PLATE VARIAX FIBULA, 7 HOLE / L96MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12582857
• MDR Text Key: 274926319
• Report Number: 0008031020-2021-00432
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252222002
• UDI-Public: 07613252222002
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 40-20807
• Device Catalogue Number: 4020807S
• Device Lot Number: G15551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 75 KG