MAUDE Adverse Event Report: BIOMET MICROFIXATION TITANIUM PECTUS ELONGATED STAB; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient identified - first initial: unknown; second initial: (b)(6).Concomitant medical product - zimmer biomet titanium pectus bar catalog #: pt-2871 lot #: 885130.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00265.
Event or Problem Description
It was reported that a revision is planned due to the lower bar flipping.The bar was noted to be flipped anteriorly 45 days post op due to poor design.The surgeon was afraid to make any changes to the bar during the surgery, based on our instructions to avoid doing anything that may compromise the strength of the bar.The revision is scheduled for (b)(6) 2019.Attempts have been made and no further information has been provided.
Event or Problem Description
Distributor michael mckelvey, reported a revision is planned due to the "lower bar flipping".
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.The pectus bar and stabilizer were returned for investigation.It was reported that 45 days post-operation the pectus bar flipped anteriorly.The distributor is requesting a new bar with a bit more bend in the tails thus resulting in a tighter fit which would better accommodate the patient.No photos, scans, x-rays, or physicians reports were provided.Because a revision surgery occurred, the complaint is confirmed.Functional testing was done by inserting the pectus bar into the stabilizer and applying force to attempt to loosen and flip the bar.The bar could not be forced through the stabilizer groove and flipped.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00265-1.

• Brand Name: TITANIUM PECTUS ELONGATED STAB
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8583794
• Report Number: 0001032347-2019-00269
• Device Sequence Number: 14033267
• Product Code: HRS
• UDI-Device Identifier: 00841036124120
• UDI-Public: 00841036124120
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K061384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 01-3802
• Device Lot Number: 958930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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