MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. LIMB HOLDER, WRIST OR ANKLE, SECURITY, 1 STRP, QR, CUFF/BED; RESTRAINT, PROTECTIVE

Model Number	M8138
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	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) security team was restraining a very combative patient (b)(6) 2024 with the deroyal m8138 restraints.They said that the patient was able to pull them through the buckle and they had to tie them to the bed.He actually hospitalized one of their officers.
Additional Manufacturer Narrative
A complaint was received on 09/20/2024 reporting (b)(6) security team was restraining a very combative patient (b)(6) 2024 with the deroyal m8138 restraints.They said that the patient was able to pull them through the buckle and they had to tie them to the bed.He actually hospitalized one of their officers.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 50 product number m8138 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.

• Brand Name: LIMB HOLDER, WRIST OR ANKLE, SECURITY, 1 STRP, QR, CUFF/BED
• 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: 20439490
• Report Number: 3010452421-2024-00006
• Device Sequence Number: 8323983
• Product Code: FMQ
• UDI-Device Identifier: 00749756946865
• UDI-Public: 00749756946865
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2024

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: M8138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/14/2024
• 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