MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM; SCREW, FIXATION, BONE

Catalog Number	656318S
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
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.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "during the intraoperative opening of the implant, the outer packaging did not come off smoothly and the inner case was dropped, making it unclean.".
Event or Problem Description
As reported: "during the intraoperative opening of the implant, the outer packaging did not come off smoothly and the inner case was dropped, making it unclean.".
Additional Manufacturer Narrative
The review of the received picture has shown that the cover of the inner sterile blister did not peel off properly on one corner.There are residues of the paper visible, which indicates that the friction was in this area higher than usual to remove the cover.Based on that the complaint can be confirmed.Just one picture of a section of the inner blister was provided, the rest of the package is not visible and the overall condition can therefore not be evaluated.The product was not returned for investigation and therefore no further product evaluation is possible.A review of the device history for the reported lot did not indicate any abnormalities.The reported lot 1000538749 was manufactured in october 2023 with lot size of (b)(4)devices and we are not aware of any other complaint of this nature for this lot.The review of the complaint history has also shown that there are no other complaints of this nature for the catalog # 656318s.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.In retrospective it cannot be defined if any occurrence during transportation, storage (e.G.Problem with humidity or temperature) or during handling (e.G.Not grapping the full cover at the indented place) did lead to improper peel off of the blister cover.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18454732
• Report Number: 0008031020-2024-00007
• Device Sequence Number: 14228254
• Product Code: HWC
• UDI-Device Identifier: 07613327070705
• UDI-Public: 07613327070705
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180500
• 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,Followup
• Report Date (Section B): 03/26/2024

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: 656318S
• Device Lot Number: 1000538749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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