MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW; POLYMER, EAR, NOSE, AND THROAT, SYNTHETIC, ABSORBABLE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical device: biomet microfixation lactosorb system 1.5 mm adjustable self-drilling tap, catalog #: 915-1595, lot #: ni; therapy date: (b)(6) 2018.Foreign country: (b)(6).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.

Event Description

It was reported the surgeon could not insert the first screw during a surgery.Then, the surgeon used this tap and made a pilot hole to other place and attempted to insert the first screw into the new pilot hole but it fractured.Then, the surgeon changed this tap to new one.After that, this new one was used to make a pilot hole and remaining seventeen screws were inserted without any problems.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for investigation and no photos were provided.For these reasons, the screw cannot be visually evaluated or functionally tested and therefore the complaint is non-verifiable.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00019-1.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: 1.5 LACTOSORB SYSTEM 1.5 X 4 MM LACTOSORB SCREW
• Type of Device: POLYMER, EAR, NOSE, AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8231397
• MDR Text Key: 132519527
• Report Number: 0001032347-2019-00020
• Device Sequence Number: 1
• Product Code: NHB
• Combination Product (y/n): N
• PMA/PMN Number: K012409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• 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: 915-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention