MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Twisted/Bent (2981)

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 ¿ 64480516.00625006535 ¿ bone screw ¿ 64557309.00875705402 ¿ 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 - 2019 - 00924.0002648920 - 2019 - 00925.

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 SCREW SELF-TAPPING
• 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
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10038881
• MDR Text Key: 190831156
• Report Number: 0002648920-2020-00249
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119833
• UDI-Public: (01)00889024119833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• 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: 64480516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1