MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X26MM LOW PRO CORT SCR STE; SCREW, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign: event occurred in (b)(6).Concomitant medical devices: item# 856135022; 3.5x22mm cort lock scr ste; lot# 757560; item# 856135024; 3.5x24mm cort lock scr ste; lot# 527340; item# unknown; unknown plate; lot#: unknown.The product will not be returned to zimmer biomet for investigation.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: 0001825034-2020-03015, 0001825034-2020-03016.Product not returned.
Event or Problem Description
It was reported that the patient underwent initial operation with alps tibia.Surgeon found distal screws had fractured at the head section.Subsequently, the patient was revised to remove the head parts and insert some screws at vacant screw hole.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Additional Manufacturer Narrative
Radiographs were provided and reviewed by a health care professional.A review of the available records identified the following: overall fit and alignment of the implants is appropriate.Normal bone quality.No signs of loosening, radiolucency, corrosion.Possible fracture of the proximal second and third screws.No contributing factors are seen.The complaint is confirmed.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 3.5X26MM LOW PRO CORT SCR STE
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10402313
• Report Number: 0001825034-2020-03018
• Device Sequence Number: 11680476
• Product Code: HRS
• UDI-Device Identifier: 00887868352454
• UDI-Public: (01)00887868352454
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 851235026
• Device Lot Number: 662250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR