MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X40MM TL13.5MM; SCREW, FIXATION, BONE

Catalog Number	604640S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "they opened a screw which turned out to be a washer.The procedure was completed successfully with another size screw.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned material and the received picture shows the package of the screw in combination with a sterile blister that contains a washer.The device inspection revealed the following: the original sterile package was returned in opened condition, the outer shrink foil was still present.The reported catalog- and lot number of the asnis cannulated screw can be confirmed based on the labels.The content was removed from the package, the paper instruction for use and the patient record labels were present and belong to the on the label described cannulated screw.The sterile blister does contain a washer as reported, the label on the sterile blister does indicate the catalog- and the lot number of the washer and not of the reported screw.The washer was removed form the sterile blister during the evaluation and it can be confirmed that the laser markings on the washer do correspond to the label on the blister, catalog number 619905s and lot number y60978.A review of the device history for the reported lot did not indicate any abnormalities.The reported screw with lot h68071 was manufactured in april 2022 and the sterile blister with the washer from lot y60978 was manufactured in march 2019.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.Based on investigation, the root cause was attributed to a usage related issue.There were 2 years between manufacturing and packaging of the affected lot numbers, based on that a manufacturing related issue can be excluded.This indicates that the package was opened and the content was replaced at some point after the screw was released for distribution in the year 2022.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "they opened a screw which turned out to be a washer.The procedure was completed successfully with another size screw.".

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X40MM TL13.5MM
• Common Device Name: SCREW, 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: 19247792
• Report Number: 0008031020-2024-00197
• Device Sequence Number: 17975120
• Product Code: HWC
• UDI-Device Identifier: 04546540089762
• UDI-Public: 04546540089762
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213199
• 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): 06/26/2024

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 Catalogue Number: 604640S
• Device Lot Number: H68071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2022
• 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