MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR FRCP LOOSEBODY PTBLL; ACCESSORIES,ARTHROSCOPIC

Catalog Number	011022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a knee arthroscopy, the surgeon was retrieving a loose body from patient using one (1) pitbull grasper sidelock handle, and the instrument broke at the tip of the grasping section.An x-ray was taken and the broken part of the instrument was at the posterior side of the tibia, and it was unable to be retrieved.There was a surgical delay greater than 30 minutes, and then the procedure was cancelled and rescheduled for another surgery.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference number: (b)(4).H2: additional information on: b5.
Event or Problem Description
It was reported that during a knee arthroscopy, the surgeon was retrieving a loose body from patient using one (1) pitbull grasper sidelock handle, and the instrument broke at the tip of the grasping section.An x-ray was taken and the broken part of the instrument was located at the posterior lateral aspect of the tibia, and it was unable to be retrieved.The fragment was subject to migration.There was a surgical delay greater than 30 minutes, and then the procedure was cancelled and rescheduled for another surgery on (b)(6) 2025 but the procedure was not successful.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The etching is faded but legible and the lot matches the complaint.The upper actuating jaw has fractured at the most proximal tooth point.The fractured piece was not received.A functional evaluation showed that the jaw actuates without resistance.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review confirmed that the externally communicating device/instrument is composed of stainless steel.The device is neither intended nor designed for long-term tissue contact; therefore, implantation data is not available.An electronic image provided shows that the opposing "serrated" tip or grasping section is absent.According to the instructions for use (ifu), careful inspection and functional testing of the device prior to use is the recommended method for determining the end of its serviceable life.Although the full extent of patient impact beyond the reported retrieval attempts of the non-implantable foreign body remains unclear, the potential for corrosion and further migration cannot be excluded.Additionally, the presence of serrated teeth on the grasper may increase the risk of localized tissue irritation, damage, or patient pain/discomfort.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: GRSPR FRCP LOOSEBODY PTBLL
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22124971
• Report Number: 1219602-2025-01332
• Device Sequence Number: 8678556
• Product Code: NBH
• UDI-Device Identifier: 03596010023025
• UDI-Public: 3596010023025
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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: 011022
• Device Lot Number: L50219212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/06/2025; 08/26/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/10/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male