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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the rib plate malfunctioned and resulted in a retained foreign body during implantation.The surgeon was using the rib plates for repair of multiple rib fractures.The surgeon proceeded to tighten the locking caps and noticed the plate separated from the locking post.This happened to only one of the posts.They were able to unscrew the other side and remove the plate, but couldn't remove the post, cap, and washer on the broken side.The malfunction resulted in a surgical delay that exceeded thirty (30) minutes.It was reported that no further information is available.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Device was not returned for evaluation.No product was returned; therefore, visual and dimensional evaluations could not be performed.Visual examination of the provided pictures identified the plate separated from the post, with components embedded in the tissue.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information 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: 11598979
• Report Number: 0001032347-2021-00161
• Device Sequence Number: 11818350
• Product Code: HRS
• UDI-Device Identifier: 00841036272395
• UDI-Public: (01)00841036272395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 323.1033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 08/11/2021
• 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: Other
• Patient Age: 30 YR