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

Catalog Number	804-03-054
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Complaint - the fixation screw is too short.
Additional 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
• Common Device Name: IMPACTION FIXTURE, RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 10523256
• Report Number: 1644408-2020-00763
• Device Sequence Number: 2822601
• Product Code: LXH
• UDI-Device Identifier: 00190446142706
• UDI-Public: (01)00190446142706
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 804-03-054
• Device Lot Number: 221597L01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other