MAUDE Adverse Event Report: BIOMET MICROFIXATION OMNIMAX SELF-DRILL CROSS-DRIVE SCREW 2.0 X 11 MM; BONE SCREW

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device product code-dzl."patients with.Insufficient quantity or quality of bone, " is listed in the contraindications in the package insert.The warnings in the package insert state this type of event can occur.The product was discarded by the hospital and therefore will not be returned for an evaluation.Because the lot number is unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.This is report 4 of 4 for the same event.Reports 1 through 3 are reported on mfr # 0001032347-2016-00295 through 0001032347-2016-00297.

Event Description

It is reported that a revision of an omnimax arch bar took place.It is reported the patient's comorbidities and dental disease made her maxilla too thin to retain the hardware.It is reported, "the forces exerted too close down her open bite with bilateral condylar fractures caused the screws to literally cerclage through the maxilla." it was also noted that "the good news for the devices is that the screws did not loosen from the plate and there was flexibility to find some bony landing points." it is reported that there were no implants used after removing the omnimax system.

Manufacturer Narrative

The product identity was confirmed through the picture provided by the distributor.The lot numbers of the parts could not be identified.A list of the potential lots where found.The product was not returned.It was discarded as biohazard by the hospital.It was reported that between two and three weeks after the original operation the upper maxillary bar pulled through her maxilla and the screws lost purchase.Customer mentions in one of the correspondences that, "the forces exerted to close down her open bite with bilateral condylar fractures caused the screws to literally cerclage through the maxilla." the intended meaning of this statement is unclear, however, this may be suggesting that the event occurred while attempting to bind the bone fragments together.Customer stated, "this lady's mandible - because of her other cormorbidities and dental disease - was mush and her sinuses were low (or conversely her maxilla was thin)." the customer also stated, "screws did not loosen from the plate and we did have the flexibility to find some bony landing points." the customer suggests that the cause of the bars dislocation is due to the patients condition and there was no malfunction of the device.They also provide statements that suggests that the part functioned as intended (screws did not loosen from plate and found fixated in bone fragments) and it was the poor condition of the patient's maxilla.For these reasons, the complaint is considered unconfirmed.The most likely underlying cause of the complaint is patient condition.There are no indications of manufacturing defects.This is report 4 of 4 for the same event.Reports 1 through 3 are reported on mfr # 0001032347-2016-00295-1 through 0001032347-2016-00297-1.

• Brand Name: OMNIMAX SELF-DRILL CROSS-DRIVE SCREW 2.0 X 11 MM
• Type of Device: BONE SCREW
• 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: 5722930
• MDR Text Key: 47321335
• Report Number: 0001032347-2016-00298
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-5711
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention