MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 HOLE / LEFT; PLATE, FIXATION, BONE

Catalog Number	628007
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Malunion of Bone (4529)
Date of Event	04/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text: device disposition is unknown.
Event or Problem Description
As reported: "fracture of the left clavicle, displaced angulated with signs of malunion due to separation of the plate from the distal end with three completely loose screws, this information was described by the specialist during the surgical finding.The failing material is removed and replaced with a new plate and placement of new and more screws on the patient.".
Event or Problem Description
As reported: "fracture of the left clavicle, displaced angulated with signs of malunion due to separation of the plate from the distal end with three completely loose screws, this information was described by the specialist during the surgical finding.The failing material is removed and replaced with a new plate and placement of new and more screws on the patient.".
Additional Manufacturer Narrative
Correction: please refer to h6 results code.The received x-rays were reviewed, and the reported event could be confirmed.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.The complaint was forwarded to medical affairs for review with following result: ¿there is limited information available.For these types of fractures 2 directions of x-rays is even more important because of the complex shape of the bone.The event can be confirmed.Although the plate itself may not have failed, the construct failed in this typical fracture.These fractures need specific attention with regard to a stable construct because of the shape of the bone and the forces on the shoulder girdle.It seems the plate is relatively short for the fracture with only two screws medially and 3 lateral of (and very close to) the fracture, in other words, a relatively short plate.Another interesting fact is the patient being a fireman.What was the aftercare? was the patient compliant etc.The general statement does apply here: based on the provided information, the root cause of the reported event is multi-factorial: the location of the fracture, the chosen implant and the technical aspects of the surgical procedure contributed to the event.Furthermore, patient activity levels post-op may also have contributed to an inadequate load distribution, and therefore the loosening of the implant.¿ no product related issue could be detected.The device was not returned for evaluation and the provided information is limited.Therefore it is not possible to determine the exact root cause of this event, as stated in the medical evaluation there are multiple factors that could have played a role.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SUPERIOR PLATE - DECREASED CURVATURE VARIAX CLAVICLE 7 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: 19339870
• Report Number: 0008031020-2024-00217
• Device Sequence Number: 20600506
• Product Code: HRS
• UDI-Device Identifier: 07613252441854
• UDI-Public: 07613252441854
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: 628007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Male