MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 9 HOLE / LEFT; PLATE, FIXATION, BONE

Model Number	628209S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that 4 months after implantation the clavicle plate broke, resulting in a revision.
Additional Manufacturer Narrative
Please note corrections to d9/h3 and h6 method codes as the device was returned for evaluation.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 product returned is broken in two at the level of the 7th screw hole.Signs of a fatigue fracture are visible with the microscopic analysis of the broken area.This gives evidence that the fracture was caused by repeated overloading of the plate.The breakage can also be confirmed on the received x-rays, the plate is displaced and in contact at the place of fracture.As a reminder, the ifu clearly states: " the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.[.] these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation." 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.Since x-rays were provided, a formal medical opinion was sought from an experienced medical expert as below: ¿[.] as far as this can be assessed with the given information the surgeon has treated well.We have a mid-shaft fracture of the left clavicle with a communition zone.The restoration of the fragment looks pretty well, the communition does not allow the placement of screws closer to each other.With the chosen screw placement, however, the lever arm on the plate is pretty high.As not only compression and tension, but also torque forces are applied to the clavicle.The plate has to withstand these forces and the area is known to come along with a pretty high failure rate.[.]¿ based on investigation, the root cause was attributed to a patient related issue.The failure was probably caused by repeated overloading of the plate.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that 4 months after implantation the clavicle plate broke, resulting in a revision.
Event or Problem Description
It was reported that 4 months after implantation the clavicle plate broke, resulting in a revision.
Additional Manufacturer Narrative
Please note corrections to d9/h3 and h6 method codes as the device was returned for evaluation.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 product returned is broken in two at the level of the 7th screw hole.Signs of a fatigue fracture are visible with the microscopic analysis of the broken area.This gives evidence that the fracture was caused by repeated overloading of the plate.The breakage can also be confirmed on the received x-rays, the plate is displaced and in contact at the place of fracture.As a reminder, the ifu clearly states: " the surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal-union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.[.] these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation." 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.Since x-rays were provided, a formal medical opinion was sought from an experienced medical expert as below: ¿[.] as far as this can be assessed with the given information the surgeon has treated well.We have a mid-shaft fracture of the left clavicle with a communition zone.The restoration of the fragment looks pretty well, the communition does not allow the placement of screws closer to each other.With the chosen screw placement, however, the lever arm on the plate is pretty high.As not only compression and tension, but also torque forces are applied to the clavicle.The plate has to withstand these forces and the area is known to come along with a pretty high failure rate.[.]¿ based on investigation, the root cause was attributed to a patient related issue.The failure was probably caused by repeated overloading of the plate.If more information is provided, the case will be reassessed.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 9 HOLE / LEFT
• Common Device Name: 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14642071
• Report Number: 0008031020-2022-00275
• Device Sequence Number: 5771356
• Product Code: HRS
• UDI-Device Identifier: 04546540687098
• UDI-Public: 04546540687098
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2022

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: 09/30/2022
• Device Model Number: 628209S
• Device Catalogue Number: 628209S
• Device Lot Number: L42948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 07/19/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/17/2022; 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male