MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.0MM CANNULATED SCREW 36MM; PLATE, FIXATION, BONE

Catalog Number	71103236S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during the osteosynthesis surgery, the head of one (1) 3.0mm cannulated screw 36mm and one (1) 3.0mm cannulated screw 40mm were broken.The procedure was resumed, after a non-significant delay, with a s+n back-up device.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, the head of the screw broke during screw placement of the osteosynthesis procedure.Reportedly, the procedure was resumed after a non-significant delay using a smith and nephew back-up device with no patient injury.The requested clinical information has not been provided as of the date of this medical investigation; therefore, definitive contributing clinical factors cannot be concluded.With the limited information provided, the patient impact beyond the reported non-significant delay and use of a back-up device cannot be determined.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 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 material specification, shall control the quality and manufacture of special quality stainless steel cannulated bar.The material can be used for surgical implants and can considered to be surgical grade stainless steel.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, surgical technique, and/or excessive forces.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.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the head of the screw broke off.This piece was not returned.This inspection was conducted by naked eye.The clinical/medical investigation concluded that, per complaint details, the head of the screw broke during screw placement of the osteosynthesis procedure.Reportedly, the procedure was resumed after a non-significant delay using a smith and nephew back-up device with no patient injury.The requested clinical information has not been provided as of the date of this medical investigation; therefore, definitive contributing clinical factors cannot be concluded.With the limited information provided, the patient impact beyond the reported non-significant delay and use of a back-up device cannot be determined.A laboratory analysis revealed that, based on this investigation, it was concluded that the heads of the 36mm and 40 mm 3.0mm cannulated screws were broken off during surgery.Aside from the two screw heads, no other fractures or defects were seen on the screws.It is not clear what initiated the screw breakage during surgery.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for 12 months did not reveal similar events for the listed device.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 material specification, shall control the quality and manufacture of special quality stainless steel cannulated bar.The material can be used for surgical implants and can considered to be surgical grade stainless steel.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, surgical technique, and/or excessive forces.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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 3.0MM CANNULATED SCREW 36MM
• 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: 19321365
• Report Number: 1020279-2024-00938
• Device Sequence Number: 7659704
• Product Code: HRS
• UDI-Device Identifier: 03596010623973
• UDI-Public: 03596010623973
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

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 Catalogue Number: 71103236S
• Device Lot Number: UNKNOWN
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 11/23/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/20/2024; 11/26/2024
• 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
• Patient Age: 38 YR
• Patient Sex: Male