MAUDE Adverse Event Report: BIOMET MICROFIXATION SCREW 2.4X16MM CANCELOUS LOCKING; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product - zimmer biomet sternalock 360 multi-implant system catalog #: 74-0004 lot: ni, zimmer biomet sternalock blu screw catalog #: 73-2418, lot #: ni, unknown sternal wires catalog #: ni lot #: ni.Therapy date - (b)(6) 2017.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded.The investigation is in process.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: 0001032347-2017-00853 and 0001032347-2017-00855.

Event Description

It was reported following the implantation, the patient was intubated for 24 hours and then weaned from the ventilator.During his rounds on the second day post-op, the surgeon noted "motion" when examining the patient.The patient is a bilateral amputee and indicated that this condition means that the patient uses his upper body more extensively.In addition, the patient was agitated and claustrophobic.The lower band of the sternalock 360 implant was torn.A revision surgery was performed and the lower sternum was rewired and replated.The patient is currently doing well.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of radiographs.Visual inspection and functional testing could not be performed due to the product not being returned.On the scan provided, it is noted that the most inferior band has fractured; there is loss of approximation of the sternum; and two screws appear to be pulled out of the bone but appear to still be locked into the plate.The two most superior plates appear to maintain approximation with all screws intact and in the bone.This evidence further substantiates the complaint as confirmed.It was gathered from the surgeon that the patient was (b)(6) and had a bmi of 40.During a conference call, he also noted "motion" of the patient during his rounds on the second day post-op.He reported that the patient is a bilateral amputee and indicated that this condition means the patient uses his upper body more extensively which indicates it could have been a contributing factor to the band tearing.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to patient condition and activity.The instruction for use (ifu) for sl360 system has the following information in the section titled possible adverse effects: 1.Poor bone formation, osteoporosis, osteolysis, osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device.2.Nonunion or delayed union which may lead to breakage of the implant.3.Migration, bending, fracture or loosening of the implant.The ifu also has the following information in the section titled warnings: while these devices are generally successful in attaining these goals, they cannot be expected to replace normal healthy bone or withstand the unsupported stress placed upon the device by full load bearing.Internal fixation devices are internal splints, or load sharing devices that align the fracture until normal healing occurs.If there is delayed union, nonunion, or incomplete healing of bone, the implant can be expected to bend, break, or fail.Therefore, it is important that immobilization of the fracture site be maintained until firm bony union (confirmed by clinical and radiographic examination) is established.The size and shape of bones and soft tissue place limitation on the size and strength of implants.Surgical implants are subject to repeated stresses in use, which can result in fatigue fracture.Factors such as the patient¿s activity level, limited blood supply, insufficient quantity or quality of bone, active or latent infection and adherence to load bearing instructions may have an effect on the performance of the implant.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: 0001032347-2017-00853-1 and 0001032347-2017-00855-1.

• Brand Name: SCREW 2.4X16MM CANCELOUS LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7104074
• MDR Text Key: 94376582
• Report Number: 0001032347-2017-00854
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 73-2416
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00841036141165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR