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

Catalog Number 011020

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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.

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
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8307737
• MDR Text Key: 135149038
• Report Number: 1219602-2019-00137
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010022967
• UDI-Public: 03596010022967
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1