MAUDE Adverse Event Report: STRYKER GMBH PLASTIC LID SPS IMPLANT CASE SCREWS 3/4 LENGTH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	901663
Medical Device Problem Codes	Problem with Sterilization (1596); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the case is old and worn in some places and releases anomalous residues during sterilization.It is therefore not possible to proceed with the sterilization nor use it.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and it matches the alleged failure.The received plastic lid sps implant case screws 3/4 length were checked visually, and we can see that there is complete black marking around the screw rack.A functional inspection was performed with a tissue wipe in which the black residual around the screws was rubbed off easily which indicates that it was the dust accumulation.A review of the labeling did not indicate any abnormalities.Due to the fact that this device was manufactured and in usage for more than 10 years of compliant performance, any material or manufacturing related issues can be excluded as this would have been evident in the beginning of life of the device.No corrective actions are required at this time.Additional information was requested for the cleaning parameters, which is not available due to which root cause could not be established, if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the case is old and worn in some places and releases anomalous residues during sterilization.It is therefore not possible to proceed with the sterilization nor use it.".

• Brand Name: PLASTIC LID SPS IMPLANT CASE SCREWS 3/4 LENGTH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 17780047
• Report Number: 0008031020-2023-00339
• Device Sequence Number: 6634535
• Product Code: LXH
• UDI-Device Identifier: 04546540370679
• UDI-Public: 04546540370679
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/04/2023

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 Catalogue Number: 901663
• Device Lot Number: M04247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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