MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VPC SCREW 2.5X26MM; SCREW, FIXATION

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during a pip arthrodesis, the surgeon was implanting a variable pitch compression screw and experienced an issue with the connection between the screw driver and the screw; the driver rotated within the screw but would not engage it.The screw remained 2mm outside the cortex.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Report source: finland.No product was returned, therefore, visual and dimensional evaluations could not be performed and the reported event could not be confirmed, however, radiographs provided show the screw positioned proud of the bone.Review of the device history record identified no related deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information was received.

• Brand Name: VPC SCREW 2.5X26MM
• Type of Device: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8413844
• MDR Text Key: 138579229
• Report Number: 0001825034-2019-01138
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K160058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 233225026
• Device Lot Number: 889290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention