MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS TABLE TOP BENDER

Model Number	N/A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00218, 0001032347-2020-00219.Medical products: pectus table top bender, part# 01-3906, lot# tb07, pectus table top bender, part# 01-3906, lot# tb02 e4 - the user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).
Event or Problem Description
It was reported the table top bender was hard to move during a procedure.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.The complaint is confirmed.The device was returned for evaluation.A visual inspection shows very heavy wear.The screw for the bender with the unk lot was received disassembled.When attempt was made to reassemble the ram assembly the threaded portion of the screw would not thread onto the bender.There is damage to the threads and as a result the assembly cannot be reassembled.There will be no dhr review as the lot number remains unknown.There are no indications of manufacturing defects.For this part 01-3906 and the previous one year (from the notification date) regarding the screw becoming cross threaded, there is a complaint rate of 2.56%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is general wear and tear from many uses and well as damage to the threads.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: PECTUS TABLE TOP BENDER
• Common Device Name: BENDER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9953974
• Report Number: 0001032347-2020-00219
• Device Sequence Number: 2416145
• Product Code: HXW
• UDI-Device Identifier: 00841036011239
• UDI-Public: 00841036011239
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 01-3906
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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