MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HA PIN {} 6MM {} 30MM X 200MM; PIN, FIXATION, THREADED

Catalog Number	71070805
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, the photograph was reviewed and revealed that the half pin is fractured.The clinical/medical investigation concluded that, one undated, unlabeled photo of a broken half pin was provided; however, it does not aid in determining the root cause of the reported adverse event.The retained half pin is composed of stainless steel for surgical implants, which is implantable.According to the report, the remaining portion of the pin is embedded in the patient¿s bone, therefore, micro-motion/and or migration is unlikely.The impact to the patient beyond the retained broken half pin, and the delay union cannot be determined since it is uncertain what actions will be taken.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for external fixation systems reveal in adverse effects that loosening or breakage of the pins, wires, or other components can happen.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with the inspection drawing, the receiving inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of special quality stainless steel bar, strip, and coil stock shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, postoperative care, patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
Event or Problem Description
It was reported that, after tsf surgery, the ha pin {} 6mm {} 30mm x 200mm broke, portion of pin was removed and a new half pin placed in a different location.Remaining portion is still integrated in bone.X-rays show retained pin.It is unknown at this point what actions are going to be taken.The patient's current status is a delayed union.No further complications were reported.
Additional Manufacturer Narrative
Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: HA PIN {} 6MM {} 30MM X 200MM
• Common Device Name: PIN, FIXATION, THREADED
• 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: 19142555
• Report Number: 1020279-2024-00782
• Device Sequence Number: 12631880
• Product Code: JDW
• UDI-Device Identifier: 03596010495532
• UDI-Public: 03596010495532
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K023921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71070805
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/20/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown