MAUDE Adverse Event Report: STRYKER GMBH SUPERIOR PLATE - INCREASED CURVATURE VARIAX CLAVICLE 8 HOLE / RIGHT; PLATE, FIXATION, BONE

Model Number	628128S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed since the two references in this event were manufactured more than a year apart, and therefore could not have been mixed up during manufacturing/ packaging.The customer service was contacted to track back where the two lot numbers were shipped after they have left stryker control, and it was found that both lots were shipped to the reporting facility.Therefore, it is most probable that the mix-up happened at the customer site.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 more information is provided, the case will be reassessed.Device disposition unknown.
Event or Problem Description
As reported: "during surgery, it was discovered that instead of the desired 8-hole clavicle plate on the right, there was an implant for the left side in the unopened sterile package.Another implant (different size) was used to complete the procedure.".

• Brand Name: SUPERIOR PLATE - INCREASED CURVATURE VARIAX CLAVICLE 8 HOLE / RIGHT
• 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: 14777013
• Report Number: 0008031020-2022-00286
• Device Sequence Number: 5779310
• Product Code: HRS
• UDI-Device Identifier: 04546540686992
• UDI-Public: 04546540686992
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 628128S
• Device Catalogue Number: 628128S
• Device Lot Number: H37303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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
• Patient Sex: Unknown