MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.5MM GUIDE WIRE; RESTRAINT, PATIENT, CONDUCTIVE

Model Number	72202189
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a surgery the plastic cap that is on guide wire, left plastic debris on the wire when it was removed.The procedure was successfully completed with a back-up device.A delay greater than 30 minutes was reported.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 72202189 1.5mm guide wire used for treatment, was not returned for evaluation.Due to product unavailability, conclusions, investigation and evaluation were limited.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.The complaint dissatisfaction points to the performance of a protective cap used during packaging vs.The actual guidewire product sold.Root cause was found to be vendor based; inefficient material curing time.The situation was corrected and an action was taken to purge old stock of the silicone caps and replace them with a different style protector to prevent the issue going forward.This lot was manufactured prior to the action.
Additional Manufacturer Narrative
H10.H3, h6: one 1.5 x 229mm guidewire not used for treatment, was returned for evaluation.The complaint dissatisfaction points to the performance of a protective cap used during packaging vs.The actual guidewire product sold.The product was opened but was unable to be used.Customer made attempt to remove one silicone cap.Evaluation confirmed that removal was extremely difficult for these caps.It required scissors or knife involved which still resulted with cap material being left behind.In addition, the wire may become bowed in the process.Root cause was determined to be material related; inefficient material curing time.The existing product was purged.A supplier process improvement was conducted to eliminate the condition.Complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation although occurrences drove an investigation resulting with a supplier process improvement.

• Brand Name: 1.5MM GUIDE WIRE
• Common Device Name: RESTRAINT, PATIENT, CONDUCTIVE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9161358
• Report Number: 1219602-2019-01211
• Device Sequence Number: 2157152
• Product Code: BRT
• UDI-Device Identifier: 03596010621542
• UDI-Public: 03596010621542
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2020

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: 02/06/2023
• Device Model Number: 72202189
• Device Catalogue Number: 72202189
• Device Lot Number: 2010535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 02/12/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/28/2019; 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1