MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM OMNIMAX SELF DRILLING X-DRIVE SCREW 2.0X7MM; BONE SCREW

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 02/05/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation traumaone system omnimax arch bar 121.16x.61mm catalog #: 01-0298 lot #: ni, biomet, microfixation traumaone system omnimax screw catalog #: ni lot #: ni.Therapy date: (b)(6) 2018.One of the two screws has been received by zimmer biomet, the second screw was discarded by the facility; the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the surgeon had issues removing two screws.During the scheduled removal of the system the surgeon experienced difficulty removing two of the screws.The surgeon yanked the screws out which caused some patient tissue to come out with the screws.There was a delay of one to two minutes and the severity is indicated as very minor.This was the surgeons first time using the system and it is believed the screws were possibly inserted at wrong angle which contributed to the difficult removal.In addition, it is reported the surgeon used a total of thirteen screws which is more than was necessary.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product identity was confirmed upon the return of one of the two screws without the original packaging.The returned product was visually inspected through the biohazardous bag and it was noted that there is still one screw locked into the arch bar.It was difficult to make further observations through the bag, but the thread appears in tact, and the screw head and tip appear to have minimal damage.The distributor indicated that the surgical technique for the product was not used, as "no, the surgeon used more screws than were necessary (i believe 13! screws were used), and the one that is included appears to have been put in at the wrong angle." the instructions for use (ifu) for this product has the following information in the section titled precautions: "6: sharp angles and small bending radii must be avoided to reduce the risk of the device breaking." this is in reference to the information provided that the screws may have been placed at an angle.It is ideal for the screws to be inserted perpendicularly or at a 90 degree angle."9.Placement sites of screws should be chosen to avoid tooth roots and compression of the tissue by the arch bar.A minimum of three screws per arch bar must be used to secure an arch bar to the maxilla or mandible.In addition, only one screw should be placed in a given slot and only two consecutive slots may be skipped between screws placed for a given arch bar." this is in reference to the information provided that 13 screws were used - there are twelve (12) slots available on a full length bar, which indicates a maximum of 12 screws can be used for it, though 13 were used for this case.Device history record (dhr) review was unable to be performed as the lot number of the devices involved in the event is unknown.There are no indications of manufacturing defects.Investigation results concluded that the reported event was due to the user not following the ifu.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.Product identity of the screw that was not returned could not be confirmed.Visual inspection and functional testing could not be performed as the product was not returned.There was no additional materials provided in the form of photographs, physician's reports, x-rays, ct scans provided to substantiate the complaint, therefore the complaint of the unreturned screw cannot be verified and the most likely underlying cause cannot be determined.The dhr was not reviewed for this product due to the lot number being unknown.There are no indications of manufacturing defects.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.Unique identifier (udi) #: (b)(4).

• Brand Name: TRAUMAONE SYSTEM OMNIMAX SELF DRILLING X-DRIVE SCREW 2.0X7MM
• Type of Device: BONE SCREW
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7333924
• MDR Text Key: 102214454
• Report Number: 0001032347-2018-00125
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: PK143336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• 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: 91-5707
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Date Manufacturer Received: 07/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention