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

Model Number	N/A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00620, 0001032347-2020-00621, 0001032347-2020-00622 concomitant medical products: 2.0 lactosorb system 2.0 x 5 mm direct drive screw, part# 915-2200, lot# 865090, 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, lot# 893700, 2.0 lactosorb system 2.0 x 5 mm direct drive screw, part# 915-2200, lot# 056430.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported that the screws could not gripped during an oral surgery.Some of the screws were too tight and some of the screws were too loose.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h2, h3, h6, h10.The customer returned qty two 915-2200 lot 865090, qty two 915-2201 lot 893700, and qty two 915-2200 lot 056430 for evaluation due to lack of retention complaint.A visual inspection of the screw showed light signs of attempted use.For further analysis the screw was returned to warsaw for further investigation by the ops manufacturing technician.The reported testing results show that the returned screws were possibly damaged as there were imprints of the driver tip in the head of most the screws.Dimensional testing could not be completed due to the damage to the screw heads.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 2.0 LACTOSORB SYSTEM 2.0 X 7 MM DIRECT DRIVE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11051049
• Report Number: 0001032347-2020-00621
• Device Sequence Number: 19492080
• Product Code: HWC
• UDI-Device Identifier: 00841036054700
• UDI-Public: 00841036054700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 915-2201
• Device Lot Number: 893700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1