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	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during unspecified surgery, the rocker ring broke inside of the patient.It is unknown how the procedure was finished.No delay was reported.No other complications were reported.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, this case reports ¿the rocker ring broke inside of the patient.¿ however, the rocker ring is an external fixation device.The rocker ring includes rods, screws, and pins which could potentially break inside the patient.The rods, screws, and pins are approved for short-term contact; however, if retained no data for long-term exposure is available.Although requested no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort cannot be determined.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A complaint history review found related failures for the listed device; 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 procedural variance or surgical technique.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: 11162535
• Report Number: 1020279-2021-00331
• Device Sequence Number: 16295612
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 07/28/2021
• 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: Required Intervention