MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW; PLATE, BONE

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported a screw could not be gripped.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.Visual evaluation of the screw showed that the hex head had some damage, possibly resulting from a failed insertion attempt into the screwdriver.Per the print for this part, the three sets of flats on the hex head must taper from (in inches).121 +.001/-.002 to.127 +.002/-.001.The flats were measured using a caliper (lp-489-330, calibration due: (b)(6) 2020).The measurements of the taper for each pair of flats were:.1160 /.1170 /.1170 to.1250 /.1245 /.1245.Per the print, all three sets of flats were out of spec on both the large and small ends of the hex head.The dhr was reviewed and there were no non-conformances found.This is the only complaint in regards to a lack of retention for 915-2301 lot 609670.For this part (915-2301) and the previous one (1) year (from the notification date) regarding the lack of retention of the screw, there is a complaint rate of 0.03% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is manufacturing issue causing the head to be manufactured undersized.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon further investigation, it was discovered that the part was examined using the incorrect inspection criteria and found to be non-conforming.When the correct inspection criteria were used to examine the device, the part was found to be conforming.The complaint is unconfirmed.Visual evaluation of the screw showed that the hex head had some damage near the top of the hex head, which is consistent with damage seen where the driver is not fully seated onto the hex.The inspection criteria for this item, i01999, states the hex function f/14 is to be inspected using gage g01123, with the note: tapered hex must fit into gage to within.050 of opposite side.Or, may extend past the opposite side up to.020.Inspector to check per specified sample level.The screw was returned to warsaw to be inspected using gage g01123.The screw passed this inspection.The most likely underlying cause of the complaint cannot be determined.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.The following fields were updated: b4 date of this report.B5 describe event or problem.G4 date received by manufacturer.G7 type of report.H2 follow up type.H3 device evaluated by manufacturer.H6 results code.H6 conclusions code.H10 additional narratives/data.

Event Description

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

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9540024
• MDR Text Key: 191470464
• Report Number: 0001032347-2020-00006
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036055028
• UDI-Public: 00841036055028
• Combination Product (y/n): N
• PMA/PMN Number: K002083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 609670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 05/26/2020; 07/22/2020
• Supplement Dates FDA Received: 05/27/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 70 YR