MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. LIMB HOLDER, WRIST OR ANKLE, SECURITY, 1 STRP, QR, 3 PT BKL; RESTRAINT, PROTECTIVE

Model Number M8139

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  Injury  

Event Description

Buckle attached to bed broke under severe pressure.There was an injury with this incident.A security guard was kneed in the ribs and sent to the emergency department to be evaluated.

Manufacturer Narrative

A complaint was received on 02/14/2024 reporting buckle attached to bed broke under severe pressure.There was an injury with this incident.A security guard was kneed in the ribs and sent to the emergency department to be evaluated.A sample of the product was returned to deroyal for evaluation.There were no issues found with the sample returned.The product did not show signs of wear and the buckle was still intact.The root cause was determined to be the design of the buckle.As a corrective action deroyal has source a new design for the buckle the male side has a small notch.The old inventory of the buckle has been discarded and the new sourced buckle is being used.Production records were reviewed, and no issues were found.An inventory check of the limb holders was made by deroyal, a total of 20 of the m8139 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, 3 PT BKL
• Type of Device: 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: 18852307
• MDR Text Key: 337071469
• Report Number: 3010452421-2024-00001
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 00749756354745
• UDI-Public: 00749756354745
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

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?: No
• Device Model Number: M8139
• Device Lot Number: 59159075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1