MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. , 3.4MM SOFT TISSUE GRASPER; ACCESSORIES, ARTHROSCOPIC

Catalog Number	0300034703
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the bottom jaw broke during knee scope and was left in patient.The surgeon attempted to retrieve the broken piece from the patient's joint space but was unable to locate the broken piece.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: jaw broke.Probable root cause: excessive force applied by user.Patient anatomy.Portal location.Incorrect instrument diameter/length.Manufacturing/servicing error.Reprocessing/handling error.Improper instrument selected.Lack of maintenance.Use error - attempting to cut improper materials.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the bottom jaw broke during knee scope and was left in patient.The surgeon attempted to retrieve the broken piece from the patient's joint space but was unable to locate the broken piece.

• Brand Name: PKG. , 3.4MM SOFT TISSUE GRASPER
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19486784
• Report Number: 0002936485-2024-00452
• Device Sequence Number: 7924702
• Product Code: NBH
• UDI-Device Identifier: 07613327053487
• UDI-Public: 07613327053487
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0300034703
• Device Lot Number: K1033JL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Male