MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.5MM GUIDE WIRE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202189
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, it was found that the plastic protective slip of the wire guide was stuck.The procedure was successfully completed without a significant delay using a back-up device.No patient injury or other 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
H10 h2, h3, h6: the reported 1.5 guidewire, intended for use inn treatment, has not been returned for evaluation.A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints have been filed and that no abnormalities were reported with this product lot during manufacture, however a trend of this nature has been observed with this product in the field, prompting a design change which will remove the silicone caps and replace them with tpu sleeves to prevent this issue going forward.

• Brand Name: 1.5MM GUIDE WIRE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10261820
• Report Number: 1219602-2020-01012
• Device Sequence Number: 3853760
• Product Code: LXH
• UDI-Device Identifier: 03596010621542
• UDI-Public: 03596010621542
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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 Model Number: 72202189
• Device Catalogue Number: 72202189
• Device Lot Number: 20455755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/11/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1