MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE GUIDE 2.0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	72202881
Medical Device Problem Codes	Difficult to Open or Remove Packaging Material (2922); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rubber end caps will not come off from guide wire, small pieces remain and guide wire is unusable.The problem happened before the procedure, and it was solved using a back up device.No delay was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3,h6: one 72202881 2.0mm guide wire intended for use in treatment, was not returned for evaluation.The complaint dissatisfaction points to the performance of a protective packaging cap vs.The actual pac product sold.Due to product unavailability, evaluation was limited.If further information becomes available the complaint may be revisited.Factors that might affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.It has been observed that the protective packaging caps removal process left a sticky silicone residue on products.Root cause was found to be vendor based; inefficient material curing time.Batch review did not indicate a condition, product or procedure failure that supported the allegation although the occurrence rate drove previous engineering evaluation and response.A supplier process improvement occurred to correct the material issue.The caps have also been replaced with alternate tip protectors.Rate of occurrence has decreased across codes that used the packaging material.Complaint history review indicated no similar allegations for the lot number reported.Results and probable cause were drawn, determined or concluded based upon files such as manufacturing documentation, dhr, complaint history, ifu, risk management, clinical/mi results, material assessment and technique guides (as applicable).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the part drawing found that the silicone tip protectors have been updated to plastic sleeves since this device was manufactured.A visual inspection revealed that the tip protectors of the guide wire stuck to the device.On one side, small pieces of the tip protector were left behind, and on the other, the tip protector could not be fully removed without tearing.The pieces could not easily be rubbed or peeled off.The complaint was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include exposure to excessive heat that would lead to the deformation of the silicone tips.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.No containment or corrective actions are recommended at this time.Corrected data: h6: health effect - clinical and impact code and medical device problem code.

• Brand Name: WIRE GUIDE 2.0MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10285921
• Report Number: 1219602-2020-01067
• Device Sequence Number: 13582174
• Product Code: LXH
• UDI-Device Identifier: 00885554000337
• UDI-Public: 00885554000337
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2023

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: 04/22/2024
• Device Model Number: 72202881
• Device Catalogue Number: 72202881
• Device Lot Number: 2031465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/11/2020; 08/23/2023
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/14/2020; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown