MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE STRAIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number	010001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a knee arthroscopy, the straight probe's tip broke off.In spite of trying to remove it for about an hour, it couldn't be removed.There was a backup device available.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported straight probe, intended for use in treatment, returned for evaluation.From the information provided, the tip broke off during use.Visual assessment confirm complaint.The tip was broken.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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: PROBE STRAIGHT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10376094
• Report Number: 1219602-2020-01183
• Device Sequence Number: 11513392
• Product Code: NBH
• UDI-Device Identifier: 03596010021533
• UDI-Public: 03596010021533
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 010001
• Device Catalogue Number: 010001
• Device Lot Number: 50771132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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: Required Intervention