MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0X7MM LACTOSORB SCREW

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet 2.0x7mm lactosorb screw catalog #: 915-2301 lot #: 66053354; zimmer biomet 2.0x7mm lactosorb screw catalog #: 915-2301 lot #: 66169236 zimmer biomet 2.0x7mm lactosorb screw catalog #: 915-2301-ea lot #: 66253376; zimmer biomet 2.0x7mm lactosorb screw catalog #: 915-2301-ea lot #: 66321061; zimmer biomet 1.5mm adjustable self-drilling tap #: 915-1595 lot #: 557203; zimmer biomet lactosorb system l-plate left regular catalog #: 915-2102 lot #: 511700; zimmer biomet lactosorb system l-plate right regular catalog #: 915-2101 lot #: 139240; zimmer biomet battery powered powerdriver catalog #: 50-1000 lot #: unknown.G2: foreign - japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during surgery, the hex head of the screws did not break properly and the screws continued to spin in the bone.There was a delay of 40 minutes as the screws were removed and the surgery was completed with other product.There were no consequences or impact to the patient.It was reported that no further information is available.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: 2.0X7MM LACTOSORB SCREW
• Common Device Name: 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19312194
• Report Number: 0001032347-2024-00158
• Device Sequence Number: 20537189
• Product Code: HWC
• UDI-Device Identifier: 00841036055028
• UDI-Public: (01)00841036055028(17)280428(10)66053354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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 Model Number: N/A
• Device Catalogue Number: 915-2301
• Device Lot Number: 66053354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown