MAUDE Adverse Event Report: ENCORE MEDICAL L.P. CANCELLOUS SCREW; SCREW, CANCELLOUS, 30MM

Model Number	010-55-030
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported incident - during a left total arthroscopy, a piece of one of the titanium screws used for the procedure broke after insertion.The broken piece (head of the screw) was removed from the surgical field and sequestered with the materials supervisor along with the manufacturer's packaging.The body of the screw remained intact and hip fixation was established.The surgeon felt that the hip socket was stable and did not elect to place any further screws.There was no harm to the patient.
Additional Manufacturer Narrative
The reason for this reported incident was due to a screw breaking after insertion.There are no reported pre-existing patient health conditions.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was not made available to djo surgical for examination.A review of the device history records, shows that the reported component, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.He root cause of this complaint was due to one screw broke after insertion.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: CANCELLOUS SCREW
• Common Device Name: SCREW, CANCELLOUS, 30MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7889265
• Report Number: 1644408-2018-00806
• Device Sequence Number: 1819545
• Product Code: HWC
• UDI-Device Identifier: 00888912069984
• UDI-Public: (01)00888912069984
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K931665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: 010-55-030
• Device Catalogue Number: 010-55-030
• Device Lot Number: 007A1245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1