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 Codes	Fracture (1260); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint cmp (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00003.Concomitant medical products: 2.0 lactosorb system 2.0 x 7 mm direct drive screw, part# 915-2201, lot# 893690.2.0 lactosorb system 2.5 x 7mm direct drive screw, part# 915-2208, lot# 769250.The user facility is foreign; therefore, a facility medwatch report will not be available.Reporter: (b)(4).
Event or Problem Description
It was reported one (1) screw could not be gripped and one (1) screw broke because it was too tight to pull out of the screwdriver during a maxillary procedure.The procedure was completed with another screw.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.One screw from lot 769250 was returned with the head and threads damaged and covered in blood.Two screws from lot 893690 were returned.One is fractured and the other is deformed and covered in blood.Item and lot numbers are confirmed to match the complaint with package labels.Dimensional testing was not completed due to damage to the screw head.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined due to the inability to dimensionally measure the product because of the product damage.A possible gauge issue was identified and an issue evaluation was previously initiated for further evaluation.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.This report is being submitted to update additional information in section b5, d4, d9, h2, h3, h6 and h10.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00003, 0001032347-2021-00238.
Event or Problem Description
It was reported two (2) screws could not be gripped and one (1) screw broke because it was too tight to pull out of the screwdriver during a maxillary procedure.The procedure was completed with another screw.No adverse events have been reported as a result of the malfunctions.

• 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: 11121455
• Report Number: 0001032347-2021-00002
• Device Sequence Number: 16315895
• 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): 05/03/2021

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: 893690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 05/03/2021
• 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