MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ROCKER RING; CRUTCH

Model Number	71070365
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an unknown procedure, it was noticed that the rocker ring broke in the back, at the s+n logo.Patient was admitted in the clinic for medical intervention.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed and the failure mode was confirmed.The clinical/medical investigation concluded that, the provided photo confirms the broken rocker ring.However, with the requested clinical information fall/trauma history or the device the root cause of the breakage cannot be determined.Per subsequent email.It was reported after the patient was admitted to the clinic for intervention, the patient is healthy, and the issue has been resolved.Therefore, no further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 not limited to traumatic injury or excessive forces applied to the device.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: ROCKER RING
• Common Device Name: CRUTCH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11023469
• Report Number: 1020279-2020-07541
• Device Sequence Number: 690561
• Product Code: IPR
• UDI-Device Identifier: 00885556012871
• UDI-Public: 00885556012871
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71070365
• Device Catalogue Number: 71070365
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention