MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BAR BENDER

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
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 instrument was missing a component and is inoperable.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection was carried out on the bender.The bender shows heavy signs of use.The thumb press mechanism is missing from the bender and as a result the bender cannot function properly.The tipqa database was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint in regards to a broken bender for 01-3905 lot 577420.The most likely underlying cause is wear and tear from multiple uses.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.
Additional Manufacturer Narrative
The following fields were updated: b4 date of this report b5 describe event or problem g4 date received by manufacturer g7 type of report h2 follow up type h4 device manufacturer date h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS BAR BENDER
• Common Device Name: BENDER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10209004
• Report Number: 0001032347-2020-00281
• Device Sequence Number: 2121351
• Product Code: HXW
• UDI-Device Identifier: 00841036011222
• UDI-Public: 00841036011222
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2020

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: 01-3905
• Device Lot Number: 577420
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/08/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/15/2020; 10/08/2020
• 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