MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACUFEX-PRO SCISSOR STR; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7207047
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zipcode (b)(6).
Event or Problem Description
It was reported that, during a cuff repair surgery, the new acufex-pro scissor broke as it was used to take a bite of soft tissue.All the device fragments were removed from within the patient.There was a backup device available.No significant delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One acufex-pro straight scissor punch was returned for evaluation.Visual assessment confirmed the reported breakage.The cutting edge/distal tip has broken free from the shaft.The cutting edges are damaged.The shaft is bent.The condition of the device indicates it was subjected to excessive force during use.Per the devices ifu ¿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.Excessive force can result in instrument failure¿.There were no indications that would suggest that the devices did not meet product specifications upon release into distribution.

• Brand Name: ACUFEX-PRO SCISSOR STR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9363218
• Report Number: 1219602-2019-01471
• Device Sequence Number: 3231299
• Product Code: NBH
• UDI-Device Identifier: 03596010252906
• UDI-Public: 03596010252906
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 7207047
• Device Lot Number: 50710577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1