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	04/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A voluntary medwatch report (# mw5153677) was received on 04/23/2024 reporting clinical 4-point restraints were applied by security officer and registered nurse as police carefully removed the police wrap.After restraints were applied, emergency room registered nurse was waiting for medication to be ordered to calm patient, as patient was continuously physically aggressive while restrained and yelling at police officers in emergency room 4.While waiting for medication, patient was able to break the right wrist restraint in half causing police officers to react and grab patient's right arm and apply hand cuffs to both left and right wrist.Shortly after patient was cuffed to bed by police, medication order came in and security officer entered emergency room 4 to assist emergency room registered nurse while giving the medication.Security then cleared and police sat and watched patient, who later was medically cleared and was discharged with police.Patient's urine drug screen was positive for illegal substances.The actual sample was not returned for evaluation however, pictures of the sample were provided to deroyal.The root cause was determined that a wear/use/handling issue most likely occurred.Based on the pictures of the sample it has been noticed that the product was used with a lot of force it appears the patient was continuously physically aggressive.Due to the root cause finding there were no corrective and or preventive actions taken.There have been no changes made to the raw material used for this limb holder.No manufacturing issues were found.Production records were reviewed, and no issues were found that would cause the reported issue.A total of 8 of product number m8135 lot 60689225 of the limb holders were randomly inspected by deroyal, and no discrepancies were identified during the inspection.No problem with the cuff was detected, nor tendency of the foam to get damaged.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
Clinical 4-point restraints were applied by security officer and registered nurse as police carefully removed the police wrap.After restraints were applied, emergency room registered nurse was waiting for medication to be ordered to calm patient, as patient was continuously physically aggressive while restrained and yelling at police officers in emergency room 4.While waiting for medication, patient was able to break the right wrist restraint in half causing police officers to react and grab patient's right arm and apply hand cuffs to both left and right wrist.Shortly after patient was cuffed to bed by police, medication order came in and security officer entered emergency room 4 to assist emergency room registered nurse while giving the medication.Security then cleared and police sat and watched patient, who later was medically cleared and was discharged with police.Patient's urine drug screen was positive for illegal substances.

• 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: 19350830
• Report Number: 3010452421-2024-00003
• Device Sequence Number: 7403877
• Product Code: FMQ
• UDI-Device Identifier: 00749756837811
• UDI-Public: 00749756837811
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/20/2024

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
• Device Lot Number: 57152671 OR 56421681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/20/2024
• 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