MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ PECTUS SUPPORT BAR; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a custom pectus bar was not the correct length.The issue was discovered after the custom pectus bar had been implanted.The custom pectus bar was removed and an alternative pectus bar was used to complete the surgery.The resultant surgical delay was twenty-five minutes.No adverse events have been reported as a result of the malfunction.
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.This complaint cannot be confirmed.Functional testing and inspections could not be performed due to the parts not being returned and no intra-operative photographs, x-rays, ct scans, or physician reports being provided.The dhr was reviewed and there were no non-conformances found.For all ps-xxxx stainless steel pectus bars in the previous one years (from the notification date), there is a complaint rate of 0.26%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint cannot be determined.It is possible that the bar was perceived as being too short if it was placed too far superior or inferior to the location used in the design.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: LORENZ PECTUS SUPPORT BAR
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8832792
• Report Number: 0001032347-2019-00370
• Device Sequence Number: 2742885
• Product Code: HRS
• UDI-Device Identifier: 00841036268909
• UDI-Public: 00841036268909
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PS-1352
• Device Lot Number: 914980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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