MAUDE Adverse Event Report: ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A. TUBULAR STOCKINETTE; COVER, LIMB

Model Number 32-1927

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: the sewing was completed without thread in the bobbin.The error occurred when not releasing that the single needle stitching was stitched with a false seam.Corrective action: the responsible operator has been informed of the issue found and instructed to make sure to sew products with the correct stitching.The operator also was informed that when the bobbin runs out of thread to check at least five units previous to the point where the bobbin ran out of thread to ensure that there is no fake stitching.The rest of the sewing personnel in the area and the quality control inspector were informed as well.The qc inspector also was instructed to check sampling during inspections to ensure products do not have fake stitching.Investigation summary: an internal complaint ((b)(4)) was received indicating that a stockinette (part 32-1927) became unsewn during use, allowing for a patient's arm to drop.The sample was received and pictures of the defective sample were shared with the manufacturing facility in guatemala.After reviewing the pictures, it was determined that the failure was due to a manufacturing error.Specifically, a single needle sewing to secure the loop binding had a false stitching.According to the device history record, no issues were found during the manufacturing process.Three units were inspected during quality control inspections.No issues were found.An inventory check was performed of product on hand.Two cases were inspected, and no issues were found.Over the last 2 years, 210 units for the reported part number have been sold.No similar issues have been reported during this same time period.This yields a complaint-to-sales ratio of (b)(4)%.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

Loop on top of the product became unsewn during a surgical case, which caused the patient's arm to drop.The product was being used to hold up the arm during shoulder surgery.

• Brand Name: TUBULAR STOCKINETTE
• Type of Device: COVER, LIMB
• Manufacturer (Section D): ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa cana; zona 3 finca morancito; villa canales, guatemala 01065 ; GT 01065
• Manufacturer (Section G): ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa cana; zona 3 finca morancito; villa canales, guatemala 01065 ; GT 01065
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, tn ; 3626112
• MDR Report Key: 10217815
• MDR Text Key: 229285116
• Report Number: 3010452421-2020-00002
• Device Sequence Number: 1
• Product Code: IPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 32-1927
• Device Lot Number: 51666574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Date Manufacturer Received: 06/05/2020
• 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