MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP TI 1.5MM X 10MM CTX SCR T4 S-T; PLATE, FIXATION, BONE

Model Number	74401510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation (2001); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a trauma surgery conducted on (b)(6) 2021 in order to reduce a metacarpal fracture, a vlp mini-mod 1.5mm straight plate 8 hole and vlp titanium 1.5mm x 10mm cortex screws were placed.However, when fixing the vlp titanium 1.5mm x 10mm cortex screws, two of them broke inside the patient, leaving the screw body inside the patient's bone.The vlp mini-mod 1.5mm straight plate 8 hole was removed.The screws remained inside the patient without generating any affectation.Surgery was resumed, after a non-significant delay, with a vlp mini-mod 2.0mm straight plate 8 hole, without any further issue.Patient was not injured beyond the incident reported, and their current health condition is stable.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, this case reports during surgery two vlp titanium 1.5mm x 10mm cortex screws, were broken inside of the patient¿s bone and the surgeon left the screw body inside of the patient's body.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported screw breakages could not be determined.The vlp titanium 1.5mm x 10mm cortex screws are comprised of titanium 6al-4v alloy, which is implantable.Since it was reported the broken screws were left in the patient¿s bone, the possibility of micro-motion and/or migration of the retained screws is unlikely.According to the report, the surgery was resumed, after a non-significant delay, with a vlp mini-mod 2.0mm straight plate 8 hole, without any further issue.Reportedly, the patient was not injured beyond the incident reported, and the patient¿s current health condition is stable.Therefore, no further clinical/medical assessment is warranted at this time.Should any other relevant patient information be provided, this complaint would be re-assessed.A review of complaint history revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: VLP TI 1.5MM X 10MM CTX SCR T4 S-T
• Common Device Name: PLATE, FIXATION, BONE
• 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: 13112935
• Report Number: 1020279-2021-08955
• Device Sequence Number: 14375817
• Product Code: HRS
• UDI-Device Identifier: 00885556489345
• UDI-Public: 00885556489345
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K143050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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 Model Number: 74401510
• Device Catalogue Number: 74401510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VLP MINI-MOD 1.5MM STRAIGHT PL 8H / 74441524.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 78 KG