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

Model Number	72202810
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).
Event or Problem Description
It was reported that, during set up for surgery, the plastic tips on the end of the "guidewire 1.5 x 229" seemed almost melted on and could not get off.A scalpel had to be used.A backup device was available to complete the procedure.There were no significant delays and no patient injuries 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, 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 a guide wire with rubber residue on both ends.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.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: 11734607
• Report Number: 1219602-2021-00972
• Device Sequence Number: 3192888
• Product Code: LXH
• UDI-Device Identifier: 00885554000207
• UDI-Public: 00885554000207
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 04/05/2024
• Device Model Number: 72202810
• Device Catalogue Number: 72202810
• Device Lot Number: 2031404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1