MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW TIBIA SPI T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23534114
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "detected metal chips in inserts for t2 alpha spi, after washing/cleaning.".
Additional Manufacturer Narrative
The reported event could not be confirmed for the nail holding screws since no metal chips or any other residues could be detected at the returned screws.The visual inspection has shown that both nail holding screws have similar stress marks above the thread.These marks were obviously caused by the damage at the nail adapter, there is no indication that these devices did contribute to the damage at the nail interface of the adapter.A functional test has shown that the nail holding screws are functional as required, both devices could be inserted into the nail without any issues.The device inspection revealed the following: 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.Based on investigation, the root cause was attributed to a user related issue that was address under a separate investigation regarding the nail adapter.The observed stress marks at the holding screws were finally a consequence of a damage at the nail adapter.If more information is provided, the case will be reassessed.

• Brand Name: NAIL HOLDING SCREW TIBIA SPI T2 ALPHA? TIBIA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18502643
• Report Number: 0009610622-2024-00029
• Device Sequence Number: 8146608
• Product Code: HSB
• UDI-Device Identifier: 07613327357981
• UDI-Public: 07613327357981
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K191271
• 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): 01/12/2024

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: 23534114
• Device Lot Number: KP490099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown