MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE WIRE 1.2MM X18 BX OF 5 STER.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	72201201
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up for an acl reconstruction surgery, it was noticed that the packaging of the guide wire 1.2 mm had a cut, compromising the sterility of the implant.There was a s+n back up device available.There was no delay reported and there was no patient involved.
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an evaluation of the customer provided image was performed and found the packaging of the guide wire has a cut.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.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 packaging sequence of guide wire, found that the operator should verify the presence of seals on all edges of the pouch and confirm the s&n seal is on the end of the pouch opposite the chevron end.Inspect s&n seals for creases or wrinkles on the seal and reject pouch if these defects are found.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an inadvertent impact event that could have occurred during device transportation, rough shipping and handling, or at customer site.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device is in the original poly bag but the cardboard box was not returned.The poly bag has a cut, through the seal and into the product space.An analysis of the customer provided image was performed and found the packaging of the guide wire has a cut.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.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 packaging sequence of guide wire, found that the operator should verify the presence of seals on all edges of the pouch and confirm the s&n seal is on the end of the pouch opposite the chevron end.Inspect s&n seals for creases or wrinkles on the seal and reject pouch if these defects are found.The root cause was associated with transportation or storage of the units.Factors that could have contributed to the reported event include an inadvertent impact event that could have occurred during device transportation, rough shipping and handling, or at customer site.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: GUIDE WIRE 1.2MM X18 BX OF 5 STER.
• 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: 18898984
• Report Number: 1219602-2024-00489
• Device Sequence Number: 17744958
• Product Code: LXH
• UDI-Device Identifier: 03596010587671
• UDI-Public: 03596010587671
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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 Catalogue Number: 72201201
• Device Lot Number: 2133938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 04/26/2024; 08/01/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/29/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2023
• 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: Female