MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X35 SELF-TAP; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) concomitant medical products: 00625006535 ¿ bone screw ¿ 64480516.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2019 - 00924.

Event Description

It was reported that during a right hip procedure, a screw was inserted after pre-drilling.The surgeon began to torque the screw to gain purchase and the screw snapped half way down with two different screws.A third screw was able to be implanted successfully.All fractured pieces were successfully removed from the patient.No known harm or impact to the patient has been reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: 00625006535 ¿ bone screw ¿ 64480516, 00875705402 ¿ continuum shell ¿ 64359486, unknown continuum instrument ¿ unknown part and lot.Complaint sample was evaluated and the event is confirmed.Three (3) trilogy screws were returned.Visual inspection identified that two screws were fractured below the top thread and the third was bent below the top thread.The bottom threads were deformed indicating insertion attempts.Sem analysis of the fractured screws revealed the fracture surface showed suspected crack initiation and exit areas and indications of a torsional overload fracture.Sheared ductile overload dimples identified near the center of the fracture surface.Eds semi-quantitative elemental analysis of the bone screw showered that it was consistent with ti-6ai-4v alloy.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00249.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during a right total hip arthroplasty, the surgeon inserted a screw after pre drilling.As he began to torque the screw it snapped half way down.The surgeon tried again with the same results.A third screw was inserted and bent.Finally a fourth screw was able to be implanted successfully.All fractured pieces were removed from the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: BONE SCR 6.5X35 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 9527471
• MDR Text Key: 190975692
• Report Number: 0002648920-2019-00925
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625006535
• Device Lot Number: 64557309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR