MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SCR S/D-LK 2.4X8MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ribfix blu 8 hole straight plt cat# 76-2601 lot#ni.Ribfix blu 12 hole prebent plt cat# 76-2602 lot#ni.Ribfix blu 12 hole prebent plt cat# 76-2602 lot#ni.Ribfix blu scr s/d-lk 2.4x8mm cat# 76-2408 lot#ni x qty: 15.Multiple mdr reports were filed for this event, please see associated reports: 0001032347 - 2021 - 00212, 0001032347 - 2021 - 00213, 0001032347 - 2021 - 00214, 0001032347 - 2021 - 00215, 0001032347 - 2021 - 00216, 0001032347 - 2021 - 00217, 0001032347 - 2021 - 00218, 0001032347 - 2021 - 00219, 0001032347 - 2021 - 00220, 0001032347 - 2021 - 00221, 0001032347 - 2021 - 00222, 0001032347 - 2021 - 00223, 0001032347 - 2021 - 00224, 0001032347 - 2021 - 00225, 0001032347 - 2021 - 00226, 0001032347 - 2021 - 00227, 0001032347 - 2021 - 00228, 0001032347 - 2021 - 00230.

Event Description

It was reported that during an initial ribfix blu procedure, after one plate had been implanted, the posterior end of the plate came off the rib and pulled the 8mm screws out.This implant was removed and that rib was left unplated.The surgeon then used 12 hole implants over the next two fractures to span the load over the ribs.In postoperative ct scans, it was noticed that screws had begun to back out and one of the plates was gradually coming off the rib.Additionally, 4 new fractures were found.No additional medical intervention is planned at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot 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.

• Brand Name: RIBFIX BLU SCR S/D-LK 2.4X8MM
• Type of Device: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11724048
• MDR Text Key: 247257135
• Report Number: 0001032347-2021-00229
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K142823
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• 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: 76-2408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other