MAUDE Adverse Event Report: ENCORE MEDICAL L.P. MANUAL SURGICAL INSTRUMENT; IMPACTION FIXTURE, RSP

Catalog Number 804-03-054

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2020

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

Complaint - the fixation screw is too short.

Manufacturer Narrative

The reason for this complaint was reported as the fixation screw is too short.This event occurred during surgery near the patient.The healthcare professional indicated this as a significant adverse event.There was not another suitable device available, however, the incident did not cause a delay in surgery and the surgery was completed as intended.The instrument was not inspected prior to surgery.The screw shown in the photos is shorter than the stem locking screw issued with the fixture.Given that the fixture has possibly been in use for over 3 years, there are multiple factors outside of the control of djo surgical, that may have contributed to this event.A review of the device history record (dhr) revealed, when released for use, the items met design and manufacturing requirements.Complaint database review showed no previous complaints and there were no indications that this instrument has a design or material deficiency.The root cause of this event is attributable to usage and handling, which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or 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.No further action is deemed necessary at this time.

• Brand Name: MANUAL SURGICAL INSTRUMENT
• Type of Device: IMPACTION FIXTURE, RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10523256
• MDR Text Key: 207745754
• Report Number: 1644408-2020-00763
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00190446142706
• UDI-Public: (01)00190446142706
• 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
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-03-054
• Device Lot Number: 221597L01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other