MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC 2.7MM T15 CRTX SCREW 16MM S-T; SCREW, FIXATION, BONE

Model Number	73823016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Injury (2348); Implant Pain (4561)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one month after a trauma procedure, the patient consults discomfort and pain.X-rays and resonances were taken to see the protruding implant aspect, and results showed a rupture of one of the peri-loc 2.7mm t15 cortex screw 16mm s-t (screw is headless).
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the x-ray photo provided confirms the broken screw.Based on the limited information provided and without the return of the device the root cause of the reported screw breakage could not be determined.The reported pain and discomfort is likely caused by the broken screw.The impact to the patient beyond the reported cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not revealed additional complaints for the listed device.Device specific batch information was not provided.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the images provided were reviewed by the investigation and medical team and confirm the screw is fractured.The clinical/medical investigation concluded that, based on the limited information provided and without the return of the device the root cause of the reported screw breakage could not be determined.The reported pain and discomfort is likely caused by the broken screw.The impact to the patient beyond the reported cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.An historical review concluded that there are no prior actions related to this product and event.A review of the instructions for use document and the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.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 are not limited to traumatic injury, excessive forces applied to implant or abnormal loading of the limb.As the fracture of the device caused pain and discomfort, the contribution of the device to the reported event could be corroborated.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.We consider this investigation closed.Additional information: d10 h6, h10.

• Brand Name: PERI-LOC 2.7MM T15 CRTX SCREW 16MM S-T
• Common Device Name: SCREW, 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: 10432181
• Report Number: 1020279-2020-04089
• Device Sequence Number: 16709090
• Product Code: HWC
• UDI-Device Identifier: 00885556069547
• UDI-Public: 00885556069547
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K082516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2022

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: 73823016
• Device Catalogue Number: 73823016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 06/19/2021; 02/03/2022
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 06/24/2021; 02/04/2022
• 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: 71823404/SUP DIST CLAV LK PL R 109MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male