MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SCREWDRIVER; SCREW DRIVER, HEX HEAD

Catalog Number 801-01-042

Device Problem Peeled/Delaminated (1454)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Instrument failure - the screw driver tips are slightly stripped out and caused the peripheral screws on the baseplate to be stripped out.There are stripped screws left in the patient.

Manufacturer Narrative

Corrected data: see d.4., d.9., d10., & h.3.Manufacturer narrative: the reason for this complaint was reported as the screws on the baseplate stripped out.The healthcare professional indicated there was a significant adverse event to the patient.There was 5 minutes delay in surgery and another suitable device was available for use.The surgery was completed as intended.The instrument was inspected prior to surgery and was found to be acceptable.Examination confirmed the complaint, the returned instruments show the hexed/boxed ends are worn, corners rounded.The reported condition could possibly be a result of heavy use, misuse, wear and care must be taken to avoid compromising their performance, refer to the ifu.A review of the device history record (dhr) revealed, when released for use, the items met design and manufacturing requirements.Complaint database review showed previous complaints but there were no indications that these instruments have a design or material deficiency.The root cause of this complaint is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that these instruments have a design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Manufacturer Narrative

Additional narrative: h 4: had 2 additional manufacturing dates not entered on fu_1 manufacture date:  9/14/18 manufacture date: 1/11/18 h 10 additional informtion for compalint history complaint database review showed previous complaints but there were no indications that these instruments have a design or material deficiency.To date number of complaints against these lot numbers: 34209l01 - 2; 276613l01 - 1; 261607l01 - 1.Summary of complaints to date: 801-01-042: 100 - functional 5;102 - dull/worn 52; 106 - locking mechanism damaged; 110 - threads damaged/galled 10; 302 - bent 1; 303 - broke/cracked/damaged 6; 805 - wear/excessive wear 2; 904 - end of life 1; (blank) 13.803-05-167 100 - functional 10; 102 - dull/worn 95; 110 - threads damaged/galled 20; 302 - bent 4; 303 broke/cracked/damaged 18; 304 - burr 1; 904 - end of life 2; (blank) 8.804-03-022 100 - functional 12; 102 - dull/worn 41;1 109 - seized/galled 1; 110 - threads damaged/galled 4; 302 - bent 4; 303 - broke/cracked/damaged 11; 306 - dent 1; 308 - gouged/nicks/scratches/chipped 1.

• Brand Name: SCREWDRIVER
• Type of Device: SCREW DRIVER, HEX HEAD
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10448778
• MDR Text Key: 205347002
• Report Number: 1644408-2020-00679
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00888912127165
• UDI-Public: (01)00888912127165
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801-01-042
• Device Lot Number: 34209L01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 10/13/2020; 12/01/2020
• Supplement Dates FDA Received: 11/13/2020; 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 803-05-167 LOT 276613L01; 803-05-167 LOT UNKNOWN; 804-03-022 LOT 261607L01; 804-03-022 LOT UNKNOWN
• Patient Outcome(s): Other
• Patient Age: 62 YR