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

Model Number	010-55-025
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint/primary surgery - the screw head broke off the shaft as the surgeon was screwing it in the acetabular cup.
Additional Manufacturer Narrative
The reason for this complaint was to report an implant malfunction, near the patient, during primary hip surgery.Another suitable device was available, and the surgery was completed as intended after a delay of 15 minutes.There are no risks or adverse conditions indicated, and the event was described as non-serious.The shaft of the broken screw remains in the patient.The head of the broken screw was disposed of, and will not be returned to djo surgical.A review of the device history record for lot 006a1319 revealed no non-conforming material reports (ncmrs) associated with the product listed in the complaint, the lower-level component (part number 01055025, lot 203g1144), or the ti6al4v raw material bar stock (part number 0215-0032pg, lot 196a1277).A review of the product complaint report (pcr) history for the 010-55-xxx family of cancellous bone screws shows there are three prior complaints for the failure mode of the screw head fracturing from the screw shaft.This is the first complaint for the incident lot number 006a1319.Also, the incident lower level component lot 203g1144 is not common to any of the prior complaints.Per the surgical technique, the screws are inserted using the universal joint screw driver and/or the modular straight hex driver, in conjunction with a straight ratcheting handle.If the surgical technique is followed correctly, powered screw drivers are not used for the placement of screws in the acetabular shell.Follow-up information was requested from the agent, and received by e-mail.The doctor was inserting/tightening the cancellous screw by hand when it failed.He was not using a power driver.The 15 minute delay was due to waiting for a synthes broken screw set to arrive, and time spent trying to remove the screw shaft from the patient.This effort was unsuccessful, so the screw shaft was left in the patient.The bone screw is implantable grade material and the fracture surface does not expose any other material that would normally be fully encased.The screw shaft, by virtue of its threaded design and its position behind the fmp cup, is not at risk of migrating out of position and causing harm.The surgeon elected to leave the screw shaft in place, and did not indicate any adverse outcomes or risks associated with this situation.This investigation is limited in scope because the incident product was not returned to djo surgical and a definitive root cause cannot be determined.The root cause identified as the reason for the complaint was fracture of the bone screw during insertion.There was no information reported that evidences a material, design, or manufacturing problem with the product.The bone screw was likely subjected to excessive torque, excessive bending stress, or both during insertion.One possible contributing factor is hard bone, but this was not reported.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: 6899486
• Report Number: 1644408-2017-00800
• Device Sequence Number: 13748539
• Product Code: HWC
• UDI-Device Identifier: 00888912069977
• UDI-Public: (01)00888912069977
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K931665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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: 06/20/2023
• Device Model Number: 010-55-025
• Device Catalogue Number: 010-55-025
• Device Lot Number: 006A1319
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 11/02/2017
• 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