MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SCREW 2.0 X 7 MM 2.0 SYSTEM 2/PACK

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Inoperable (1663); Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Udi #: (b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.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.

Event Description

It is reported that during a procedure of lefort i osteotomy, the screw was thin and could not fit in the hole.The surgery was completed with emergency screws with less than ten minutes delay.It is reported that no foreign body was retained by the patient.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Based on the product return, the following were updated: device available for evaluation?, date received by mfr?, if follow-up, what type?, device evaluated by mfr?, evaluation codes, and additional mfr narrative.

Manufacturer Narrative

The product identity was confirmed in the evaluation.Visual inspection reveals that the screw is fully intact and has minimal damage to the threads.The product's outer diameter was measured with a micrometer and found to be within the tolerance that is called out on the drawing for this part.The part was functionally tested by inserting the screw into a hole that was created in white oak.Functional testing showed that the screw functioned as intended.The screw was easily inserted and maintained good retention.The part was found to be within the tolerances outlined on the drawing and was found to function as intended; therefore the complaint is unconfirmed.The most likely underlying cause of this complaint could not be determined as the complaint was unconfirmed.There are no indications of manufacturing defects.

• Brand Name: LACTOSORB SCREW 2.0 X 7 MM 2.0 SYSTEM 2/PACK
• Type of Device: LACTOSORB 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: 6185627
• MDR Text Key: 62746639
• Report Number: 0001032347-2016-00762
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 269240
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/04/2017; 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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): Required Intervention