MAUDE Adverse Event Report: BIOMET MICROFIXATION RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00464, 0001032347-2020-00129, 0001032347-2020-00130.Concomitant medical products: ribfix system 8 hole straight plate, part# 76-2601, lot# unk, ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 10 mm, part# 76-2410, lot# unk, ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 12 mm, part# 76-2412, lot# unk.The user facility is foreign; therefore a facility medwatch report will not be available.Foreign report source: (b)(6).The complaint is confirmed.The ribfix blu 8 hole straight plt (part# 76-2601, lot# unk, qty 2), ribfix blu scr s/d-lk 2.4x10 mm (part# 76-2410, lot# unk, qty 8), and ribfix blu scr s/d-lk 2.4x12 mm (part# 76-2412, lot# unk, qty 7) were returned for investigation.The screw part numbers were identified during the investigation.Visual evaluation of the returned products confirmed that two plates were fractured.The non-conformance database could not be reviewed for these products due to the lot numbers being unknown.There are no indications of manufacturing defects.For this part (76-2410) and the previous one year (from the notification date) regarding the fracturing of a plate, there is a complaint rate of 0.02% which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the plate fracturing could not be determined from the image and the details provided.It was noted during the review of the scan that each of the 8 holes in the two fractured plates was occupied by a screw.The ifu for this product suggests not placing screws on or near the fracture line, so it is possible this may have contributed to the failure of the device.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 or Problem Description
It was reported that two rib plates fractured post-operatively.An open reduction and internal fixation was performed in which ribs five, six, seven and nine were plated on the right side.At a later unspecified date, an x-ray revealed that the plates on ribs seven and eight were fractured.A revision occurred at a later unspecified date to remove the fractured implants.No additional patient consequences were reported.

• Brand Name: RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9772286
• Report Number: 0001032347-2020-00129
• Device Sequence Number: 16690521
• Product Code: HRS
• UDI-Device Identifier: 00841036184209
• UDI-Public: 00841036184209
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2020

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: 76-2410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR