MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.0MM CANNULATED SCREW 50MM; PLATE, FIXATION, BONE

Model Number	71103250S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during trauma surgery, the specialist was using a 3.0mm cannulated screw 50mm, and when trying to insert one of them, it broke through the threaded guide and did not allow the complete insertion.It broke at the level of the head.The pieces that fell inside the patient were retrieved, and the surgery was completed, after a non-significant delay, with a smith and nephew back-up device.The patient's current health status is stable.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
D9, h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did confirm the stated failure mode.The device's screw head was found to be fractured from the body, rendering the device inoperative.Both of the fractured pieces were returned together.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.The clinical/medical evaluation concluded that a medical review of the case was performed.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on the information provided on the pilgrim intake form, the device breakage occurred during use inside of the patient and all the broken pieces were retrieved and none of the broken pieces fell inside of the patient¿s wound.According to the report, the surgeon completed the surgery after a non-significant delay with a s&n back-up device.There was no report of harm to the patient because of this event or the non-significant surgical delay.Since it was reported the patient current health status is well, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files 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.According with material specification, it shall control the quality and manufacture of special quality stainless steel cannulated bar.As the device broke and it was required a backup device, the contribution of the device to the reported event could be corroborated.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 additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
It was reported that, during trauma surgery, the specialist was using a 3.0mm cannulated screw 50mm, and when trying to insert one of them, it broke through the threaded guide and did not allow the complete insertion.It broke at the level of the head.The pieces were retrieved.The surgery was completed, after a non-significant delay, with a smith and nephew back-up device.The patient's current health status is stable.

• Brand Name: 3.0MM CANNULATED SCREW 50MM
• 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: 15718477
• Report Number: 1020279-2022-04661
• Device Sequence Number: 14670955
• Product Code: HRS
• UDI-Device Identifier: 03596010624017
• UDI-Public: 03596010624017
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

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: 71103250S
• Device Catalogue Number: 71103250S
• 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: 10/10/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 11/28/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/09/2022; 11/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 80 KG