MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDEWIRE 1.5 X 229 (9 ); ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	72202810
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery, the rubber protection covering the ends of the guide wire of the screw was not removed and was fused with it; in this way the guide wire was unusable, because the rubber cannot be removed.The attempt was made with multiple wires of the same lot.The procedure was completed with a competitor device.No delay or patient injuries were reported.
Additional Manufacturer Narrative
The devices have not been returned for evaluation.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.
Additional Manufacturer Narrative
One unopened 1.5 guidewire was returned for evaluation.The protective caps were attempted to be removed on the device and were found unmanageable to remove by hand.A design change which will remove the silicone caps and replace them with tpu sleeves to prevent this issue going forward.

• Brand Name: GUIDEWIRE 1.5 X 229 (9 )
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8838780
• Report Number: 1219602-2019-00888
• Device Sequence Number: 2587399
• Product Code: LXH
• UDI-Device Identifier: 00885554000207
• UDI-Public: 00885554000207
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: IT
• 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): 10/24/2019

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 Expiration Date: 01/09/2023
• Device Catalogue Number: 72202810
• Device Lot Number: 2009999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 10/23/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/27/2019; 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1