MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN 12 HOLE RIB PLATE; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Inflammation (1932); Irritation (1941); Pain (1994); Pneumothorax (2012); Discomfort (2330); Malunion of Bone (4529)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.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: 0001032347-2021-00068.Two plate identities were provided for the implantation surgery, but the identity of the fractured plate was not provided.The plate may be either of the following entries: ribfix system 8 hole straight plate, part# 76-2601, lot# ni, udi (b)(4).Ribfix blu system 12 hole pre-bent plate, part# 76-2602, lot# ni, udi (b)(4).Concomitant medical products: ribfix system 8 hole straight plate, part# 76-2601, lot# ni.Ribfix blu system 12 hole pre-bent plate, part# 76-2602, lot# ni.Ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 8mm, part# 76-2408, lot# ni.Ribfix blu system screw, emergency, cancellous x-drive locking, part# 76-2708, lot# ni.

Event Description

It was reported the patient underwent a revision to remove rib fixation devices on the left 10th rib due to plate fracture and loose screw three (3) years following implantation.Prior to the revision, the patient reported she was exercising and felt a pop in her chest with a sharp pain.Imaging revealed one (1) fractured plate and one (1) loose screw.The patient underwent removal of all hardware and partial rib resection due to surrounding irritation.A partial pneumothorax was discovered and corrected during the procedure.The patient was discharged the next day without complication.It was reported that no further information is available.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.Medical records were provided and reviewed by a health care professional.It was reported that a patient underwent an orif with unknown plate and screws of the 10th posterolateral rib due to a soccer injury on (b)(6) 2016.The plate and screws were later revised due to an unknown implant failure.Subsequently, the patient reported she was exercising and felt a pop in her chest with a sharp pain.Radiology scans revealed a fractured plate and loose screw.On (b)(6) 2019, the patient underwent removal of all hardware and partial rib resection due to surrounding irritation.A partial pneumothorax was discovered and corrected during the procedure.The patient was discharged the next day without complication.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Photographs were received that capture the fractured plate.Two (2) plates were originally implanted and the plate identities were as follows: ref 762601 lot unk straight plate 8 hole, and ref unk lot unk 12 hole plate.The photos show a fractured plate with at least nine (9) holes and ref 762601 lot unk straight plate 8 hole is not applicable.This report is being submitted to update additional information in section d1, h2, and h10.

Event Description

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

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d4, g3, h1, h2, and h10.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 further event information is available at the time of this report.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.One (1) ribfix plate were returned.Inspection of the plate confirms it has fractured and all the pieces were returned.The 76-2602 ribfix blu 12 hole prebent plt only had 10 holes in it and one end appears to have been cut.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Analysis performed by optical microscope and sem (scanning electron microscope) on the ribfix plate sample showed that the fractured surfaces were excessively smeared as well as obscured with biological debris.There was no conclusive evidence identified on the fracture surfaces of the ribfix plate sample to determine the mode of failure.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.

• Brand Name: UNKNOWN 12 HOLE RIB PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11320961
• MDR Text Key: 231588493
• Report Number: 0001032347-2021-00067
• 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: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 76-2602
• Device Lot Number: J046520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 55