MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE RASP; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201661
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder procedure, when scraping the cuff, the knife broke into the middle.The broken pieces were removed from the patient.There was no delay or patient injuries but it is unknown how the procedure was finished since no backup device was available to complete it.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported knife rasp, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional 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 was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The reported knife rasp, intended for use in treatment, has been returned for evaluation.Visual assessment confirmed the reported complaint.The shaft has broken free from the handle.The shaft is bent.There are no material voids at the break area.The condition of the device indicates it was subjected to excessive forces during use.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint and manufacturing records was performed and there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: KNIFE RASP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9272635
• Report Number: 1219602-2019-01368
• Device Sequence Number: 163874
• Product Code: NBH
• UDI-Device Identifier: 03596010606297
• UDI-Public: 03596010606297
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 01/10/2020

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 Catalogue Number: 72201661
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/03/2019; 01/09/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/04/2019; 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR