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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. TOTAL KNEE PACK A & B GENERAL SURGERY TRAY

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DEROYAL INDUSTRIES, INC. TOTAL KNEE PACK A & B GENERAL SURGERY TRAY Back to Search Results
Model Number 89-5796
Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
Event Type  Malfunction  
Manufacturer Narrative

Investigation summary: an internal complaint ((b)(4)) was received indicating that, during a bilateral total knee procedure, fibers were noticed in both knees. These fibers appeared to come from the lap sponges packaged in the total knee tray (part 89-5796, lot 50635750). A sample was returned november 1 for review. The sample consisted of reported fibers inside of specimen cups and one lap sponge. The sample was shipped for decontamination and photos were sent november 1 to the supplier, us medco. The work order was reviewed for possible discrepancies that may have contributed to the reported issue. No discrepancies were identified. The bill of materials for the finished good was reviewed, and the affected raw material was identified as 1818-1, an 18x18 lap sponge contained within the convenience kit. This raw material is supplied to deroyal by us medco. The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints. A similar complaint was identified, and a scar was issued to us medco. As of the date of this report, a response has not been received. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.

 
Event Description

During a bilateral total knee replacement procedure, a fiber was noticed in both knees. The fiber appeared to come from the lap sponges contained in the convenience kit.

 
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Brand NameTOTAL KNEE PACK A & B
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette, tn TN 37766
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1501 east central avenue
lafollette, tn TN 37766
Manufacturer Contact
sarah bennett
200 debusk lane
powell, tn, TN 37849
8653626112
MDR Report Key9377516
MDR Text Key208393216
Report Number3005011024-2019-00015
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK842648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-5796
Device LOT Number50635750
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/01/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2019
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

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