MAUDE Adverse Event Report: STRYKER GMBH PERIOSTEAL ELEVATOR, STANDARD PRO

Catalog Number	705487
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon went to use the item and has explained it had debris coming off the handle in theatre.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The provided pictures shows debris coming off the handle in theatre.Those debris can be seen on the user¿s hand.Therefore, the event can be confirmed based on this picture.The device inspection revealed the following: the handle shows no visible damage or wear of any kind.There was no debris or residue observed on the handle, or coming off of it.The handle was rubbed and tapped against a paper towel in order to observe any potential debris or residues that might fall from it.No debris or residues were observed.Therefore, the reported event could not be reproduced during the investigation.Since no residue was noticed on the device, it is possible that the contamination (if any) could be removed successfully upon decontamination at the inspection site.In addition, the nature of the residues cannot be identified solely based on the provided picture.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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.Since the reported event could not be reproduced, the nature of the debris and the root cause cannot be identified.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the surgeon went to use the item and has explained it had debris coming off the handle in theatre.

• Brand Name: PERIOSTEAL ELEVATOR, STANDARD PRO
• Common Device Name: ELEVATOR
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21518747
• Report Number: 0008031020-2025-00372
• Device Sequence Number: 18531766
• Product Code: HTE
• UDI-Device Identifier: 07613327338737
• UDI-Public: (01)07613327338737(10)AK5824
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/14/2025

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: 705487
• Device Lot Number: AK5824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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