MAUDE Adverse Event Report: ENCORE MEDICAL L.P. CANCELLOUS BONE SCREW; SCREW, CANCELLOUS, 25MM

Model Number	010-55-025
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Date of Event	10/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient complaining of discomfort.The screw was a little too long.
Additional Manufacturer Narrative
The reason for this revision surgery was the patient complained of discomfort.The in-vivo length of patient service for the implant was 1 year.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.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 disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported components used in the previous surgery met design and manufacturing requirements.There was a non-conforming material report (ncmr) (b)(4) associated with the part 010-55-025, bone screw, fmp which documents a nonconformance that out of (b)(4) lot all items were rejected due to major scratch on the shaft and were accepted with a justification of scratches does not affect the dimensional conformity of product.Also, all items met the fit, design and functional requirements.The device and its applicable concomitant devices were within their respective expiration dates 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.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to patient's discomfort.Agent has mentioned that the screw was a little too long, it seems that the event may have occurred due to incorrect implant selection, improper surgical technique, degenerative bone disease or patient bone deterioration.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: CANCELLOUS BONE SCREW
• Common Device Name: SCREW, CANCELLOUS, 25MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 7029653
• Report Number: 1644408-2017-00969
• Device Sequence Number: 1145324
• Product Code: HWC
• UDI-Device Identifier: 00888912069977
• UDI-Public: (01)00888912069977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K931665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 10/14/2022
• Device Model Number: 010-55-025
• Device Catalogue Number: 010-55-025
• Device Lot Number: 006A1261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 12/12/2017
• 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: 411-00-000, LOT 902B1962; 497-34-000, LOT 636C1086; 931-34-750, LOT 760N1918
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR