MAUDE Adverse Event Report: STRYKER GMBH ADJUSTABLE FORCEPS, SIZE 8, 10 & 12 EASYCLIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	XPI006001
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that: "xpi002001 which is the single size forceps for ez10 broke during an operation today.The patient received the operation, and no adverse events occurred.".
Additional Manufacturer Narrative
Corrected field: product long description (d1), catalog no.(d4), and product available to stryker (d9).The reported event could be confirmed although the device was not returned but an image was shared which confirms the alleged failure.A device inspection was not possible since the affected device was not returned.However, an image was shared by the customer with a top view of the forceps where it could be observed, although not very clearly, that one of the prongs was broken off.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that: ""xpi002001 which is the single size forceps for ez10 broke during an operation today.The patient received the operation, and no adverse events occurred.".

• Brand Name: ADJUSTABLE FORCEPS, SIZE 8, 10 & 12 EASYCLIP
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21894677
• Report Number: 0008031020-2025-00748
• Device Sequence Number: 14313401
• Product Code: LXH
• UDI-Device Identifier: 07613252266099
• UDI-Public: (01)07613252266099(10)Y56030
• 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): 06/25/2025

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: XPI006001
• Device Lot Number: Y56030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2019
• 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