MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RING 155MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71070114X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ring was implanted on (b)(6) 2020.Now the ring is broken, but the construction is still in place on the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, the provided photos confirm the full ring 155mm is broken into several pieces.However, it was reported the construction is still in place on the patient.Per subsequent e-mail, no relevant clinical information will be provided for inclusion in the medical investigation.Therefore, the root cause of the reported breakage cannot be determined.Based on the limited information provided, the surgeon has planned a date to remove the tsf and the patient is doing well.Therefore, the impact to the patient beyond that which has already been reported, cannot be determined.Should any additional relevant medical information be provided, this complaint would be re-assessed.A visual inspection confirmed the full ring 155mm is broken into several pieces.The device shows significant signs of wear/usage.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.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 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, used in treatment, was returned and evaluated.A visual inspection confirmed the full ring 155mm is broken into several pieces.The device shows significant signs of wear/usage.The clinical/medical evaluation concluded that the provided photos confirm the full ring 155mm is broken into several pieces.However, it was reported the construction is still in place on the patient.Per subsequent e-mail, no relevant clinical information will be provided for inclusion in the medical investigation.Therefore, the root cause of the reported breakage cannot be determined.Based on the limited information provided, the surgeon has planned a date to remove the tsf and the patient is doing well.Therefore, the impact to the patient beyond that which has already been reported, cannot be determined.Should any additional relevant medical information be provided, this complaint would be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 file and instructions for use documents revealed this failure mode and potential harm was previously identified.Damage from misuse or rough handling are likely probable causes of 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 for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: FULL RING 155MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10788086
• Report Number: 1020279-2020-06159
• Device Sequence Number: 3645086
• Product Code: KTT
• UDI-Device Identifier: 00885556119563
• UDI-Public: 00885556119563
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2021

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 Model Number: 71070114X
• Device Catalogue Number: 71070114X
• Device Lot Number: 20BSM0413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 06/11/2021; 08/04/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 06/16/2021; 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 116