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	Injury (2348)
Date of Event	01/01/1901
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the full ring 155mm was implanted on (b)(6) 2020 and it was noticed that now the device is broken.The construction is still in place on the patient.No information about how the issue will be resolved or patient status was initially given.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per complaint details, upon completion of the ps box preparation and while removing the preparation guide the screw in the thumbscrew broke.Reportedly, however, the procedure was completed with the same device without delay and all pieces were recovered.It was communicated that the operative notes were not available for inclusion in the medical investigation.Patient impact beyond the reported event would not be anticipated as the box prep was reportedly already complete, all pieces were recovered, and the patient is reportedly well.No further medical assessment is warranted at this time.A visual inspection confirmed the full ring 155mm is cracked.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.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.
Event or Problem Description
It was reported that the full ring 155mm was implanted on (b)(6) 2020 and it was noticed that the device was broken.The implant was removed in (b)(6) 2020.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 10700813
• Report Number: 1020279-2020-05525
• Device Sequence Number: 19816650
• 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
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71070114X
• Device Catalogue Number: 71070114X
• Device Lot Number: 19HSM0575
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 04/09/2021; 08/25/2022
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 04/15/2021; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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: Other
• Patient Sex: Unknown