MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / RIGHT; PLATE, FIXATION, BONE

Model Number	628227S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/31/2020
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
As reported: "at (b)(6) hospital, the first operation was performed on (b)(6) 2019 using 7 holes of variax clavicle superior lateral plate.The operation was completed without any problems, but in (b)(6) 2020, the patient picked up a heavy object during work and felt discomfort in the clavicle and visited a hospital.As a result of the medical examination, breakage of the plate was confirmed.The revision was scheduled for (b)(6), but it was canceled due to the impact of covid 19.On (b)(6), at (b)(6) hospital, a non-union was confirmed and revision surgery was performed using a plate.".
Event or Problem Description
As reported: "at tokorozawa akio hospital, the first operation was performed on(b)(6) 2019 using 7 holes of variax clavicle superior lateral plate.The operation was completed without any problems, but in (b)(6) 2020, the patient picked up a heavy object during work and felt discomfort in the clavicle and visited a hospital.As a result of the medical examination, breakage of the plate was confirmed.The revision was scheduled for (b)(6) , but it was canceled due to the impact of covid 19.On (b)(6), at (b)(6) , a non-union was confirmed and revision surgery was performed using a plate.".
Additional Manufacturer Narrative
The reported event could be confirmed, as the device was returned and matched the alleged failure mode.The x-rays sent were reviewed by stryker's medical expert.The clinical statement is the following: "no union occurred at the fracture site and thus the load on the plate was to high after a while.From experience it takes pretty long for these clavicle shaft fractures to heal ( up to a year) and thus non-union and failure of the fixation device is not that rare.Without the pre-operative and direct postoperative x-ray one cannot say whether poor repositioning of the plate contributed to the non-union." therefore, the root-cause of the event could not be determined.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 complaint report will be updated.

• Brand Name: SUPERIOR LATERAL PLATE VARIAX CLAVICLE 7 HOLE / RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10165265
• Report Number: 0008031020-2020-01703
• Device Sequence Number: 3573244
• Product Code: HRS
• UDI-Device Identifier: 04546540687135
• UDI-Public: 04546540687135
• Combination Product (Y/N): N
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 02/29/2024
• Device Model Number: 628227S
• Device Catalogue Number: 628227S
• Device Lot Number: D23169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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
• Patient Age: 51 YR