MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; ORTHOPEDIC TRAY

Model Number PHS393024007A

Device Problems Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problems Syncope (1610); Pain (1994); Diaphoresis (2452); Foreign Body In Patient (2687)

Event Date 03/26/2019

Event Type  malfunction  

Event Description

On three separate occasions, 11 blades included in arthroscopy packs have become detached from the handle during use, and in some cases the 11 blade has broken into multiple pieces.Event 1: patient had left shoulder arthroscopy, labral repair with capsulorrhaphy, cyst decompression.They were discharged home the same day.Patient presented to the er two days later for syncope episode.Family member was changing shoulder dressing and patient became diaphoretic and passed out and was brought to er.Patient having shoulder pain post op but other than this feeling well.Cardiac workup and lab results normal.Patient discharged home and told to follow-up with pcp in two days.Patient went to see his surgeon and surgeon got an x-ray of the patient's shoulder.On x-ray, an 11 blade was found.Patient taken to outside facility to have 11 blade removed.Event 2: surgical blade used for incision came off of knife handle inside of knee cavity during knee scope procedure.While retrieving blade, the blade broke into 4 pieces.2 large pieces immediately retrieved and 3rd piece retrieved with aid of c-arm.Blade was reassembled and we discovered that the very tip 2mm of blade was still missing.A plane film was obtained in anterior/posterior and lateral and was read by radiologist.Per dr.There was no visible remnant of blade retained in patient.It is believed to be flushed out with arthroscopic irrigation.Event 3: during a shoulder arthroscopy while surgeon was making an incision into the skin the surgical blade broke (11 blade).All of the pieces were retrieved.In each of these events, staff were focused on documenting correct counts and did not save the broken devices.We have reminded staff to retain devices and product information in the future.Manufacturer response for arthrogram tray, medline industries, inc.(per site reporter).The manufacturer will be following up on the multiple blade issues with the blade source for the custom surgical packs.Manufacturer response for orthopedic tray, medline industries, inc.(per site reporter).The manufacturer will be following up on the multiple blade issues with the blade source for the custom surgical packs.Manufacturer response for orthopedic tray, medline industries, inc.(per site reporter).The manufacturer will be following up on the multiple blade issues with the blade source for the custom surgical packs.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 8721652
• MDR Text Key: 148761812
• Report Number: 8721652
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10889942689866
• UDI-Public: (01)10889942689866
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PHS393024007A
• Device Catalogue Number: PHS393024007A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8760 DA
• Patient Weight: 79