MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM ELONGATED PECTUS STABILIZER; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, concomitant medical products: lorenz pectus support bar, catalog #: ps-1279, lot #: 899190.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00281.
Event or Problem Description
It was reported the patient underwent a revision due to bar rotation.During the surgeons rounds on post-op day three (3), the patient reported pain.Patient examination and imaging confirmed bar rotation.A re-operation was performed on post-op day three (3) to correct the rotation and add a stabilizer.No product was removed.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of evidence suggesting the revision was performed for the stated issue and addition of the stabilizer.The products were not returned for investigation, as these parts remain implanted.It was reported that the products were implanted on 12 apr 2019 and the bar rotated 60-72 hours later.The patient reported pain and imaging showed the bar rotated, however, these images were not provided.A revision then took place to correct the rotation, therefore the complaint is confirmed.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to insufficient bar stability, the issue was corrected by adding the stabilizer as the fiber wire alone was not able to do so.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.The ifu for these products (01-50-1049_reve pectus sys) states in the section titled 'warnings and precautions': the implant can become dislodged, shift, or flip as a result of improper device selection, improper stabilization, not suturing the device(s), or patient activity too soon after surgery.Even though the implant is mechanically fixed (sutured) in position, care is to be taken to assure that the device is rigidly in apposition to the area of the deformity, as demonstrated by total or partial elimination of the visible deformity.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00281-1.

• Brand Name: PECTUS SYSTEM ELONGATED PECTUS STABILIZER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8612718
• Report Number: 0001032347-2019-00282
• Device Sequence Number: 16774820
• Product Code: HRS
• UDI-Device Identifier: 00841036011093
• UDI-Public: 00841036011093
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K981789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3801
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 12 YR