MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK 1.5MM X 5MM; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown skulpio plate, part# unk, lot# unk; this is not a zimmer biomet product.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 two screws fractured during implantation of a custom cranial plate which resulted in a delay greater than thirty minutes.One screw fragment was removed and one broken screw could not be removed.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection was conducted.Two screws show heavy scarring on screw head but are intact, two screws show heavy wear and have fractured where screw head meets the screw body.The dhr will not be reviewed as the lot number remains unknown.There are no indications of manufacturing defects.For this part (95-6105) and the previous one year (from the notification date) regarding the fracturing of this screw, there is a complaint rate of 0.1% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause is the screws experienced excessive force beyond what they are designed to take.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; d10 device availability; g4 date received by manufacturer; g7 type of report h2 follow up type; h3 device evaluated by manufacturer; h6 method code; h6 results code; h6 conclusions code; h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: 1.5MM SYSTEM HIGH TORQUE (HT),SD,X-DR,SCR,5/PK 1.5MM X 5MM
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9825628
• Report Number: 0001032347-2020-00162
• Device Sequence Number: 16601242
• Product Code: JEY
• UDI-Device Identifier: 00841036056667
• UDI-Public: 00841036056667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 95-6105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR