MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE PIN 3.2MM X 343MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631436
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, when opening the box of a guide pin 3.2mm x 343mm it was found that there were two pieces of paper (lid) overlapping.Surgery was completed with the same device without any delay.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was not returned with the packaging.The device was used in surgery.The package was returned with the double adhesive labels.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device packaging shows signs of double adhesive being used.Probable causes of this event include a manufacturing process error.This issue was evaluated through our internal quality process and a quality hold was initiated for this event, which was determined to be isolated.However, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GUIDE PIN 3.2MM X 343MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12485547
• Report Number: 1020279-2021-06932
• Device Sequence Number: 4891984
• Product Code: HSB
• UDI-Device Identifier: 00885556158371
• UDI-Public: 00885556158371
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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 Model Number: 71631436
• Device Catalogue Number: 71631436
• Device Lot Number: 21FSM0141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2021
• 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