MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS BAR BENDER; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
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.The user facility is foreign; therefore a facility medwatch report will not be available.
Event or Problem Description
It was reported that a pin in a pectus bar bender broke during surgery.An alternative table press was utilized to complete the task of bending the pectus bar.The surgical delay was less than thirty minutes.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 pectus bar bender (part#: 01-3905, serial#: (b)(4)) was returned for evaluation.The bender roller pin fractured and has separated from the bender completely.The dhr was reviewed and no non-conformances were found.There are no indications of manufacturing defects.The complaints history for the past calendar year was reviewed for this lot 491690 and no additional failures were found.The most likely underlying cause is the instrument experienced force in excess of what it was designed to encounter.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.Lot and serial number of the device was determined upon product receipt.

• Brand Name: PECTUS BAR BENDER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8832785
• Report Number: 0001032347-2019-00369
• Device Sequence Number: 2587237
• Product Code: HRS
• UDI-Device Identifier: 00841036011222
• UDI-Public: 00841036011222
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K972420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: 491690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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