MAUDE Adverse Event Report: DJO LLC DONJOY; PLAYMAKER II, X-ROM, M, BLACK

Model Number	11-0021-3
Medical Device Problem Codes	Mechanical Problem (1384); Unintended System Motion (1430); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the red button broke and will not lock out.The root cause of the complaint is damaged component based on other devices that have been evaluated.The devices lock button failed during manufacturer testing confirmed to be the same malfunction found in report number 9616086-2023-00007.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
It was reported that the red button broke and will not lock out.
Additional Manufacturer Narrative
It was reported that the red button broke and will not lock out.The device was returned to enovis for evaluation, product was used, defective hinge right side don't lock, issue reported by the customer has been confirmed.The root cause of the complaint is damaged component based on other devices that have been evaluated.The devices lock button failed during manufacturer testing confirmed to be the same malfunction found in report number 9616086-2023-00007.

• Brand Name: DONJOY
• Common Device Name: PLAYMAKER II, X-ROM, M, BLACK
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, mexico CA 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 20219170
• Report Number: 9616086-2024-00072
• Device Sequence Number: 20695608
• Product Code: ITQ
• UDI-Device Identifier: 00190446752035
• UDI-Public: 00190446752035
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: C037495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 11-0021-3
• Device Lot Number: TJ75203240425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/14/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown