MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SCREW 2.0 X 5 MM 2.0 SYSTEM 2-PACK

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

A review of the device history records show the lot 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 3 of 4, 2.0 mm screws were not able to be fixed into the bone.First tapping was used in order to make four holes for the screws, then the screws were inserted.1 screw was able to be inserted.However, when the three other screws were inserted, torque did not work and kept rotating without breaking the screws.There was no issue found with the tap when checked by the sales associate in the office.The 3, 2.0 mm screws were replaced with 3, 2.5 mm emergency screws to complete the procedure.This event did not result in a delay in the procedure.

Manufacturer Narrative

None of the alleged screws were returned for evaluation.The most likely underlying cause of this complaint is non verifiable as the alleged screws were not returned.The non-conformance database was reviewed and no non-conformances were found.There are no indications of manufacturing defects.Based on the evaluation, the following were updated: date received by mfr, if follow-up, what type?, and additional mfr narrative.

• Brand Name: LACTOSORB SCREW 2.0 X 5 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: 5729006
• MDR Text Key: 47513134
• Report Number: 0001032347-2016-00300
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

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: 03/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 915-2300
• Device Lot Number: 607610
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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