MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX ADVANTAGE LONG BRIDGE & 23MM POSTS; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it was not returned by the facility; 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: 0001032347-2020-00550.Concomitant medical products: ribfix advantage short bridge & 23mm posts, part# 323.1013, lot# ni.Ribfix advantage long bridge & 23mm posts, part# 323.1033, lot# ni.Unknown anterior rib plate, part# ni, lot# ni, unknown manufacturer.
Event or Problem Description
It was reported the rib plate post was not long enough to go through the patient's rib resulting in a three (3) hour surgical delay.The bridge post would not come through the pilot hole enough for the locking cap to engage with the threads.The surgeon drilled the pilot hole perpendicularly and was pulling up on the cable while another surgeon was applying pressure to the bridge from inside the chest.It is possible tissue or a callous prevented the bone from approximating.The displaced fractured was plated with an alternative product.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: RIBFIX ADVANTAGE LONG BRIDGE & 23MM POSTS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10784363
• Report Number: 0001032347-2020-00551
• Device Sequence Number: 19743973
• Product Code: HRS
• UDI-Device Identifier: 00841036272395
• UDI-Public: 00841036272395
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K141241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 323.1033
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 05/17/2021
• 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: Required Intervention