MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SYSTEM 11" PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report sources: brice, h., lacroix, v., pirotte, t.& docquier, p.(2018)."lung middle lobe laceration needing lobectomy as complication of nuss bar removal." case reports in orthopedics, volume 2018, pages 1-6.Https://doi.Org/10.1155/2018/8965641.Notrica, d., mcmahon, l., johnson, k., velez, d.A., mcgill, l.C., & jaroszewski, d.E.(2014)."life-threatening hemorrhage during removal of a nuss bar associated with sternal erosion." annals of thoracic surgery, vol.98 (no.3), pages 1104¿1106.Http://dx.Doi.Org/10.1016/j.Athoracsur.2013.10.097.
Event or Problem Description
It was reported in a journal article that the patient experienced life threatening bleeding after removal of a pectus bar.A (b)(6) woman presented for elective removal of her nuss pectus bars.She had undergone repair of pectus excavatum 3 years earlier.At her 3-year followup, she had excellent correction with resolution of all preoperative symptoms.During the bar removal, the prior incisions were opened bilaterally.Both bars had moderate heterotopic ossification as well as fibrin sheath encasement.Both bars were freed of all bony fragments and completely straightened.The lower bar was removed first without difficulty.The upper bar initially showed significant resistance to removal.With an additional effort, the straightened bar was removed.Immediately after the bar¿s exit, a rapid flow of non-pulsatile bright red blood flowed from both incisions.The patient rapidly became tachycardiac and hypotensive.Transfusion protocols and conversion to anterior thoracotomy were initiated.The right inframammary incision was extended to open the right chest.There was no blood in the right chest or pericardium.The anterior thoracotomy incision was extended to the left side.Bone cutters were required to cut across the heterotopic ossification where the bars crossed the ribs.The hemorrhage stopped spontaneously during exploration after extension of the left thoracotomy.Bleeding cessation correlated temporally with hypotension and the administration of epinephrine.At the site of bar erosion into the sternum, the internal mammary arteries (imas) were not visible and were assumed to be incorporated into the sternum.As this was the suspected site of bleeding, proximal ligation was performed bilaterally of the imas to decrease the risk of rebleeding.Chest drains were placed.The patient did not experience cardiac arrest or require chest compressions.Estimated blood loss was approximately 3.5 l.She received 4 units of packed red blood cells, 1 unit of fresh-frozen plasma, and 1 pheresis of platelets.At discharge, her hemoglobin was 8.4 mg/dl.Her repair has remained stable, and she recovered fully.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The surgeon sent a response stating that the bleeding the patient experienced was related to patient condition.
Event or Problem Description
The surgeon sent a response stating that the bleeding the patient experienced was related to patient condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Based on the information and materials provided, the complaint is confirmed.Functional testing and inspections could not be performed due to the parts not being returned.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.In a response from the surgeon, the surgeon stated the bleeding experienced was due to patient condition and was not related to the implant.There are no indications of manufacturing defects.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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS SYSTEM 11" PECTUS SUPPORT BAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8527978
• Report Number: 0001032347-2019-00230
• Device Sequence Number: 13935121
• Product Code: HRS
• UDI-Device Identifier: 00841036011017
• UDI-Public: 00841036011017
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/01/2019; 08/07/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/30/2019; 08/09/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTHREX FIBERWIRE CATALOG #: NI LOT #: NI; ARTHREX FIBERWIRE CATALOG #: NI LOT #: NI
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 19 YR