MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. LIMB HOLDER, WRIST OR ANKLE, HEAVY DUTY PSYCHIATRIC; RESTRAINT, PROTECTIVE

Model Number	M8135
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received reporting patient was being placed in restraints for self-injurious behavior.Patient was combative and pulling at the restraint while staff was attempting to apply.A piece of the restraint broke off.The plastic piece broke as a result of patient aggression.Per nursing leadership review, the restraints were applied correctly and additional restrain education is being provided.The triangles on the norix platform bed were not being utilized during the above event.The sample was not returned for evaluation and no lot number was provided.The potential root cause was determined that a wear/use/handling issue most likely occurred.Based on the reported issue it appears the patient was very combative.Due to the root cause finding, there were no corrective or preventive actions taken.There have been no changes made to the raw material used for this limb holder.No manufacturing issues were found during the inventory check.An inventory check was made by deroyal.A total of 13 product number m8135 limb holders were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
Patient was being placed in restraints for self-injurious behavior.Patient was combative and pulling at the restraint while staff was attempting to apply.A piece of the restraint broke off.The plastic piece broke as a result of patient aggression.Per nursing leadership review, the restraints were applied correctly and additional restrain education is being provided.The triangles on the norix platform bed were not being utilized during the above event.

• Brand Name: LIMB HOLDER, WRIST OR ANKLE, HEAVY DUTY PSYCHIATRIC
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; canales zona 3 finca morancito; villa canales, 01065, guatemala ; GT
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; canales zona 3 finca morancito; villa canales, 01065, guatemala ; GT
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 20734118
• Report Number: 3010452421-2024-00007
• Device Sequence Number: 9161642
• Product Code: FMQ
• UDI-Device Identifier: 00749756837811
• UDI-Public: 00749756837811
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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
• Device Model Number: M8135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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