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

Model Number	72202810
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during setup for an arthroscopy after opening the guide wire, it was observed that the rubber protector on either end were melted and could not be successfully removed, even with the nursing staff using a scalpel.There was backup device available and no delay or 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
H3,h6: the reported device, intended for use in treatment was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found melted plastic on the ends of the device.A review of the device history records showed there were no indications to suggest that the lot did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the drawing found that the silicone tip protectors have been changed to plastic sleeves since the manufacture of this device.The change was implemented due to customer feedback that the silicone tip protectors were difficult to remove.The complaint was confirmed and the root cause was associated with transport and storage.Factors which could have contributed no containment or corrective actions are recommended at this time.

• Brand Name: GUIDEWIRE 1.5 X 229 (9 )
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10871252
• Report Number: 1219602-2020-01880
• Device Sequence Number: 4002071
• Product Code: LXH
• UDI-Device Identifier: 00885554000207
• UDI-Public: 00885554000207
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/14/2021

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: 02/19/2023
• Device Model Number: 72202810
• Device Catalogue Number: 72202810
• Device Lot Number: 50715404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 06/10/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 01/04/2021; 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1