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 and pectus table top bender, part# 01-3906, lot# tb02.The user facility is foreign; therefore, a facility medwatch report will not be available.Report resource - japan.
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.
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 bender lot number 030816b16 has cross threaded and is unable to be removed.The dhr was reviewed for lot 030816b16 and no non-conformances were found.There are no indications of manufacturing defects.For this part 01-3906 lot 030816b16 regarding the screw becoming cross threaded, (b)(4).For this part 01-3906 and the previous one year (from the notification date) regarding the screw becoming cross threaded, (b)(4).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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: PECTUS TABLE TOP BENDER
• Common Device Name: BENDER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9953983
• Report Number: 0001032347-2020-00218
• Device Sequence Number: 2416146
• 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: 030816B16
• 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