MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RING 155MM; PIN, FIXATION, THREADED

Model Number	OR71070114X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ring broke 3 months after being implanted on the patient.After the fracture was detected, the defective ring was stabilized with an additional ring.The surgeon keeps the construction in place on the patient.The patient outcome is unknown.
Additional Manufacturer Narrative
Additional info: d4, d10, g4, g7, g9, h2, h3, h4, h6, h10.Results of investigation: the device, used in treatment, was not returned for evaluation as it remains in use.A clinical analysis indicated that the photos provided confirms the reported event.Based on the limited information provided the root cause of the reported full ring breakage could not be determined.The impact to the patient beyond the reported events cannot be concluded.No further clinical assessment is warranted at this time.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 product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Product support engineers were made aware of this occurrence.A review of the risk management file and instructions of use for the product was completed.Factors and/or some potential probable causes that could include but not limited to materials not adequate for indications and traumatic injury.Without the return of the actual product involved, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: FULL RING 155MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9831311
• Report Number: 1020279-2020-00874
• Device Sequence Number: 16328691
• Product Code: JDW
• UDI-Device Identifier: 00885556119563
• UDI-Public: 00885556119563
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K994143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2021

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
• Operator of Device: No Information
• Device Expiration Date: 04/23/2019
• Device Model Number: OR71070114X
• Device Catalogue Number: OR71070114X
• Device Lot Number: 19DSM0823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 08/25/2021
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 10/09/2020; 08/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 91