MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR ALGTR STR 2.7MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	011020
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a knee arthroscopy the pinch broke inside the patient's knee.Then they tried several times to remove the piece but did not succeed.A check was done by x-rays (intraoperative).This has lead to the opening of the knee, an increase of the withers time, 15 minutes of operative arthoscopic gesture for 1h10 minutes of opening time and antibioprophylaxy.It is unknown if a back up device was available.A delay greater than 2 hours was reported.
Additional Manufacturer Narrative
One 2.7mm alligator grasper was returned for evaluation.The device is 23 yrs.Old and exhibits expected wear and tear.Visual assessment of the device confirmed the reported complaint.The upper jaw has returned and has broken off where it transitions into the lug.The lug portion of the jaw remains attached to the shaft.The normally sharp teeth of the jaws are rounded over.The condition of the device indicates it was subjected to excessive force during use.Per the devices instructions for use under precautions: ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.¿.

• Brand Name: GRSPR ALGTR STR 2.7MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8307737
• Report Number: 1219602-2019-00137
• Device Sequence Number: 1304264
• Product Code: NBH
• UDI-Device Identifier: 03596010022967
• UDI-Public: 03596010022967
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 011020
• Device Lot Number: L696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1