MAUDE Adverse Event Report: ZIMMER BIOMET, INC. THREADED PIN 3.2 MM DIAMETER 508 MM LENGTH; ROD, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00249004732, threaded pin 3.2 mm diameter 508 mm length, 63945303.Report source, foreign - the event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001822565 - 2018 - 03261.

Event Description

It was reported that 3.2mm guide wire tips from guide wires broke off inside the patient twice when positioning the guide wire for the lag screw.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that 3.2 mm guide wire tips from guide wires broke off inside the patient twice when positioning the guide wire for the lag screw.The wire tip fragments were left in situ and it is unknown if these will be explanted at a later date.No further patient consequences have been reported.Attempts have been made and additional information on the reported event is unavailable.

Event Description

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

Manufacturer Narrative

The x-rays provided were sent to hcp for review.Their review confirmed the presence of foreign bodies in the patient's femur.However, the precise location of the pieces cannot be determined on these fluoroscopic images.The more proximal piece, seen on all three views, appears to be external to the femoral head and there is insufficient visualization to determine bone quality.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned device confirmed fracture near the threads and the threaded portion was not returned.Also noted heavy galling on the shafts.Dimensions taken are within specification.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.  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

Correction: udi# - (b)(4).

• Brand Name: THREADED PIN 3.2 MM DIAMETER 508 MM LENGTH
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7604989
• MDR Text Key: 111161422
• Report Number: 0001822565-2018-03262
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00249004732
• Device Lot Number: 63955242
• Other Device ID Number: (01) 00889024063952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability