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

Model Number	628108S
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during a clavicle case.The surgeon requested the 8 hole increased curvature.The left plate from the loan tote, which had the plastic wrap still on the outside, was retrieved and the label in the box was checked with the surgeon and opened from the label end.Then found there was no plate inside the box.The surgery was completed by using the right sided clavicle plate on the left clavicle.
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.H3 other text: item missing from box.
Additional Manufacturer Narrative
The received pictures were reviewed.On none of the pictures is the complete package or the complete sterile pouch visible, therefore it cannot be confirmed if the device is in the package or not.One picture shows a part of the sterile pouch.There is a clear discoloration at the weld seams on both sides of the pouch.These marks show that the pouch was pull opened at some point post-manufacturing.The complained device was not returned for evaluation, therefore no further evaluation is possible.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.No manufacturing related issue could be detected, the received pictures show that the sterile pouch was opened post-manufacturing.But in retrospective it cannot be defined where, when or by whom this was made.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that during a clavicle case the surgeon requested the 8 hole increased curvature.The left plate from the loan tote, which had the plastic wrap still on the outside, was retrieved and the label in the box was checked with the surgeon and opened from the label end, then found there was no plate inside the box.The surgery was completed by using the right sided clavicle plate on the left clavicle.

• Brand Name: SUPERIOR PLATE - INCREASED CURVATURE VARIAX CLAVICLE 8 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: 17297885
• Report Number: 0008031020-2023-00273
• Device Sequence Number: 3863669
• Product Code: HRS
• UDI-Device Identifier: 04546540686978
• UDI-Public: 04546540686978
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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 Expiration Date: 02/28/2026
• Device Model Number: 628108S
• Device Catalogue Number: 628108S
• Device Lot Number: H27732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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