MAUDE Adverse Event Report: BIOMET MICROFIXATION SCREW 2.4X16MM CANCELLOUS 5PK; STERNAL FIXATION DEVICE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 03/04/2021

Event Type  Injury  

Event Description

It was reported a patient underwent a revision surgery approximately 1 week postimplantation due to the implanted cup being torn distally from the sternum.The surgeon did not adhere to the recommendation to use several cups or one ladder cup.Wire cerclages were used to complete the revision.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: sl blu 60d jl 12 holes plate; cat#sp-3215; lot#unk.Screw 2.4x16mm cancellous 5pk 4x16mm; cat# 73-5416; lot#ni -qty:7.Scrw 2.4x14mm cancelous lockng; cat# 73-2414; lot#ni.Scrw 2.7x14mm cancelous lockng; cat# 73-2714; lot#ni.Scrw 2.7x16mm cancelous lockng; cat# 73-2716; lot#ni.Report source: (b)(6).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.It is alleged that the surgeon did not use several plates or a large ladder plate.The ifu for these products (01-50-1215) recommends 5 cuttable rigid plate sections to close a complete mid-line sternotomy.However without medical records a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00126, 0001032347-2021-00544, 0001032347-2021-00545, 0001032347-2021-00546, 0001032347-2021-00547, 0001032347-2021-00548, 0001032347-2021-00549, 0001032347-2021-00551, 0001032347-2021-00552, 0001032347-2021-00553.

• Brand Name: SCREW 2.4X16MM CANCELLOUS 5PK
• Type of Device: STERNAL FIXATION DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12918934
• MDR Text Key: 285320160
• Report Number: 0001032347-2021-00550
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 73-5416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention