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

Model Number 71070114X

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 01/01/1901

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 212046685
• Report Number: 1020279-2020-05525
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00885556119563
• UDI-Public: 00885556119563
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 71070114X
• Device Catalogue Number: 71070114X
• Device Lot Number: 19HSM0575
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 04/09/2021; 08/25/2022
• Supplement Dates FDA Received: 04/15/2021; 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other