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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Swelling (2091)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00426.Medical products: pectus system 11in pectus support bar, part# 01-3711, lot# ni.Pectus system elongated pectus stabilizer, part# 01-3801, lot# 407120.(b)(6).The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).

Event Description

It was reported that patient experienced poor wounding healing, swelling and edema at the surgical site three (3) weeks following implantation of a pectus support bar.The patient received symptomatic treatment for more than one (1) month.Following treatment, the incision healed and the edema disappeared.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed because it was reported additional treatment was done to resolve the issue.The device not returned for investigation and no photos, scans, x-rays, or physician's reports were provided.For these reasons, no functional testing or inspections could be performed.The non-conformance database was reviewed; no non-conformances were found.There are no indications of manufacturing defects.There have been two complaints regarding post-operative incision non-union and effusion for this item# 01-3711, lot# 6541083.For this part (01-3711) in the previous one year (from the notification date) regarding post-operative incision non-union and effusion, there is a complaint rate of 0.34% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined.Possible causes for post-operative incision non-union could include not following proper wound closure techniques, patient condition, or activity level.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

This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS SYSTEM 11IN PECTUS SUPPORT BAR
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10499547
• MDR Text Key: 205894157
• Report Number: 0001032347-2020-00425
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036011017
• UDI-Public: 00841036011017
• Combination Product (y/n): N
• PMA/PMN Number: K972420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-3711
• Device Lot Number: 6541083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• 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): Required Intervention
• Patient Age: 13 YR