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

Catalog Number	011021
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a meniscus resection, the mobile part of the working part of the device broke off.The piece remained in the knee joint.There was a delay of more than 60 minutes.The doctor did not have a backup device available, so an arthrotomy was executed.
Event or Problem Description
It was reported that during a meniscus resection, the mobile part of the working part of the device broke off.The piece remained in the knee joint.There was a delay of more than 60 minutes.The doctor did not have a backup device available, so an arthrotomy was executed.The extraction of the fragment was not carried out, the patient is doing well.
Additional Manufacturer Narrative
One (b)(4) curved upbiter alligator grasper instrument returned for evaluation.This is a three year old reusable device.The complaint stated: ¿as reported: during the operation, the mobile part of the working part of the device broke off.Remained in the knee joint, the doctor failed to pull it out.¿ it was relayed that the jaw broke.The allegation was confirmed.The top articulating jaw component has been severed.The piece was not returned.This symptom has been found to be consistent with excess torque having been applied to the instrument.This typically occurs during twisting, pulling or lifting of tissue and bone.It has also been found to be consistent with long term use and sterilization methods; ie: getting damaged and entangled with other instruments or devices whole loaded into baskets.¿prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.These instruments are designed for repeated use with proper care and handling.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.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿ final product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: GRSPR ALGTR UPBTR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8448302
• Report Number: 1219602-2019-00342
• Device Sequence Number: 2989553
• Product Code: NBH
• UDI-Device Identifier: 03596010022998
• UDI-Public: 03596010022998
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/17/2019

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: 011021
• Device Lot Number: 50619496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 04/04/2019; 05/16/2019; 05/16/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/02/2019; 04/04/2019; 05/17/2019; 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Weight: 103