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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Swelling (2091)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS SYSTEM 11IN PECTUS SUPPORT BAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10499547
• Report Number: 0001032347-2020-00425
• Device Sequence Number: 19573743
• Product Code: HRS
• UDI-Device Identifier: 00841036011017
• UDI-Public: 00841036011017
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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
• Device Lot Number: 6541083
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR