MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5X18MM LOW PRO CORT SCR STE; SCREW, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).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 report will be submitted.
Event or Problem Description
It was reported that during the procedure, the implant fractured and all pieces were removed from the patient's wound.Another screw was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10 corrected: h6 patient code: the patient did not retain a foreign body as initially reported.Visual inspection of the returned product noted the head is fractured, confirming the complaint.The product was sent to sem for additional evaluation.Screw sample analyzed by sem showed that its fracture surface consisted of excessive smearing likely due to post-fracture damage and evidence of overload fracture.Crack initiation site could not be identified on the fracture due to excessive smearing on the screw which obscured the details.A region of fracture on the screw showed sheared ductile overload dimples indicating the crack propagation direction.There were no indications of fatigue mode of fracture identified in the non-smeared areas on the screw fracture surface.However, the primary mode of fracture and crack initiation couldn¿t be determined.Eds semi-quantitative elemental analysis of the screw showed that it was consistent with ti-6al-4v alloy.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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: 3.5X18MM 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: 9672886
• Report Number: 0001825034-2020-00303
• Device Sequence Number: 2923126
• Product Code: HRS
• UDI-Device Identifier: 00887868055102
• UDI-Public: (01)00887868055102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 851235018
• Device Lot Number: 020790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1