MAUDE Adverse Event Report: ENCORE MEDICAL L.P. BONE SCREW; SCREW, CANCELLOUS, 60MM

Model Number	010-55-060
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as removal of screws from the tibial baseplate.The previous surgery and the surgery detailed in this event occurred 13 years and 2 months apart.All four screws were removed per attached email.Unable to determine which screw was the main contributor.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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a non-conformance associated with the main part, which documents that out of 12 parts lot, 1 part was scrapped in pouch sealer seal operation.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to removal of screws from the tibial baseplate.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - screws needed to be removed from tibial baseplate.No component failure present.

• Brand Name: BONE SCREW
• Common Device Name: SCREW, CANCELLOUS, 60MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9779836
• Report Number: 1644408-2020-00128
• Device Sequence Number: 16322089
• Product Code: HWC
• UDI-Device Identifier: 00888912070058
• UDI-Public: (01)00888912070058
• 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: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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: 05/28/2010
• Device Model Number: 010-55-060
• Device Catalogue Number: 010-55-060
• Device Lot Number: 260612A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 010-55-060 LOT 260612B; 391-09-610 LOT 53795063
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR