MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 6.5 MM CANCELLOUS BONE SCREW; SCREW, CANCELLOUS, 30MM

Model Number	010-55-030
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reason for this revision surgery was reported as screw-head broke upon implantation.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.Device evaluation anticipated, but it will take few weeks as it has to go through a process at eisenhower.A review of the device history record (dhr) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) 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 the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a screw-head broke upon implantation.There were no findings during this evaluation that indicate the reported device was defective.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Instrument failure - the 30mm screw head broke upon implantation.70 percentage of it stayed in the patient.

• Brand Name: 6.5 MM CANCELLOUS BONE SCREW
• Common Device Name: SCREW, CANCELLOUS, 30MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10013935
• Report Number: 1644408-2020-00362
• Device Sequence Number: 2937769
• Product Code: HWC
• UDI-Device Identifier: 00888912069984
• UDI-Public: (01)00888912069984
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K931665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2020

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 Expiration Date: 02/18/2026
• Device Model Number: 010-55-030
• Device Catalogue Number: 010-55-030
• Device Lot Number: 007A1347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR