MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRASPER CUPPED 3.4MM EXTENDED 2.25; ACCESSORIES,ARTHROSCOPIC

Model Number	7207700
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hamstring repair, the grasper broke inside the patient.All broken pieces were removed from the patient.Delay of 0-30 min was reported.It was not reported if a smith & nephew device was available.The procedure was successfully completed.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: the reported 3.4mm grasper cupped extended 2.25, used in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint records was performed.In the event additional information or the device is returned the complaint will be revisited.Further investigation is not warranted at this time.

• Brand Name: GRASPER CUPPED 3.4MM EXTENDED 2.25
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9612332
• Report Number: 1219602-2020-00118
• Device Sequence Number: 547787
• Product Code: NBH
• UDI-Device Identifier: 03596010474834
• UDI-Public: 03596010474834
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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 Model Number: 7207700
• Device Catalogue Number: 7207700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR