MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 4.5 MM DIA. 40 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial hip arthroplasty, the screw broke during the placement of the osteosynthesis plate, a piece remained in the patient's bone.The screw was left in the patient's bone because the removal trial could have damaged the plate.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.  the following sections were.Updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.  a trilogy bone screw was returned.Visual evaluation identified the following: the screw was fractured.The fracture piece was retained in the patient's body.The hex head exhibited nicks and scratches indicative of implantation attempts.No other damages were noted.Further analysis identified the following: the bone screw's fracture surface showed suspected crack initiation and exit areas.Sheared ductile overload dimples were present throughout the fracture surface.Material analysis of the bone screw confirmed that the material was consistent with ti-6al-4v alloy.No further evaluation could be performed with the returned product.Complaint sample was evaluated and the reported event was confirmed.Evaluation of the returned product does not change the final conclusions of previous investigation.The root cause could not be determined with the information provided.A summary of the investigation has been sent to the complainant.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

No further event information available at the time of this report.

• Brand Name: BONE SCREW SELF-TAPPING 4.5 MM DIA. 40 MM LENGTH
• 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: 10200179
• MDR Text Key: 196591282
• Report Number: 0002648920-2020-00315
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119765
• UDI-Public: (01)00889024119765(17)290831(10)64485654
• Combination Product (y/n): N
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00625004540
• Device Lot Number: 64485654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other