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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAY Back to Search Results
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.

 
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Brand NameMEDLINE INDUSTRIES, INC.
Type of DeviceORTHOPEDIC TRAY
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
1 medline place
mundelein IL 60060
MDR Report Key8721652
MDR Text Key148761812
Report Number8721652
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received06/21/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPHS393024007A
Device Catalogue NumberPHS393024007A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2019
Device Age0 yr
Event Location Hospital
Date Report TO Manufacturer06/21/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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