MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL TIP GUIDE WIRE 2.4MM; PASSER

Model Number	014396
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, when the package of the drill was opened, the film did not come off from the sterilization patch and the device became filthy.The procedure was successfully completed without 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
One 2.4mm drill tip guide wire intended for use in treatment, was returned for evaluation.The complaint dissatisfaction points to the performance of that protective packaging cap not the guidewire product itself.This instrument calls for a foam tube style tip protector.The product was opened but was unable to be used.Customer made attempt to remove the cap.Evaluation confirmed that removal was extremely difficult, leaving residue behind.Factors that may affect device performance include device storage or transportation for extended periods of time in extremely high or low temperature possibly altering the composition of materials.Product met specs upon release to distribution.Complaint history review indicated no similar allegations for the lot number reported.
Additional Manufacturer Narrative
The reported 2.4 mm drill tipped guide wire, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, when the package of the drill was opened, the film did not come off from the sterilization patch and the device became filthy.An exact root cause cannot be determined with confidence without the return of the device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DRILL TIP GUIDE WIRE 2.4MM
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10383079
• Report Number: 1219602-2020-01200
• Device Sequence Number: 1167863
• Product Code: HWQ
• UDI-Device Identifier: 03596010374691
• UDI-Public: 03596010374691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K920621
• 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): 09/17/2020

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 Expiration Date: 08/26/2024
• Device Model Number: 014396
• Device Catalogue Number: 014396
• Device Lot Number: 2039390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 09/15/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 09/07/2020; 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1