MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM PROVISIONAL FIXATION PIN 30MM; PIN, FIXATION, THREADED

Catalog Number	71174914
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an internal fixation surgery, the tip of one (1) 2.0mm provisional fixation pin 30mm broke off in patient.The broken piece was very small and not visible on x-ray.The procedure was resumed, without any delay, using a s+n back-up device.Health status of patient is currently unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
B5: event description) e1: name of reporter.
Event or Problem Description
It was reported that, during an internal fixation surgery, the tip of one (1) 2.0mm provisional fixation pin 30mm broke off in patient.The broken piece was very small and not visible on x-ray.The procedure was resumed, without any delay, using a s+n back-up device.Patient is in good health.
Additional Manufacturer Narrative
Additional information: b2.H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited information provided, the definitively clinical root cause of the reported fracture tip could not be determined.The retained non-implantable tip is comprised.The 2.0mm provisional fixation pins are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.Consequently, it is unclear if the broken tip was left secured inside of the patient.Therefore, we cannot rule out the potential for micro-motion, and/or migration, local skin irritation and pain.Nor can we make any conclusions on the impact of the retained non-implantable foreign body to the patient.According to the report, the procedure was completed without any delay, using a smith and nephew back-up device.Since it was reported the patient is in good health no further clinical/medical assessment is warranted at this time.The patient impact is determined to be the retained tip, since it was reported the patient is in good health.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 instructions for care, maintenance, cleaning, and sterilization of smith & nephew orthopedics devices for single-use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.Reuse may increase risk of breakage, failure, patient infection, patient injury and revision surgery.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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.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.B1, h1, h6 (health effect - clinical code and health effect - impact code).

• Brand Name: 2.0MM PROVISIONAL FIXATION PIN 30MM
• 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: 19332230
• Report Number: 1020279-2024-00948
• Device Sequence Number: 17893432
• Product Code: JDW
• UDI-Device Identifier: 00885556386996
• UDI-Public: 00885556386996
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

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: 71174914
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: Not provided; 06/14/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/22/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 23 YR
• Patient Sex: Male