MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X4MM HT SD X-DR SCR EA; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE

Catalog Number	91-6104
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the surgeon went to implant the screws, the tip of the screw did not insert correctly.The surgeon changed out the screws and proceeded with the case.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: 1.5x3.5mm ht sd x-dr scr ea, cat# 91-6103, lot# 737860.Report source: (b)(6).A visual inspection was completed on both of the returned screws.The tips for both screws are missing.The screws both show signs of attempted use including marking on the screw heads as well as damage to the tips and the surrounding anodize.A determination cannot be made as to what caused the damage to the screw tips.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00021.

• Brand Name: 1.5X4MM HT SD X-DR SCR EA
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, NON-STERILE
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 13192763
• Report Number: 0001032347-2022-00022
• Device Sequence Number: 12258101
• Product Code: JEY
• UDI-Device Identifier: 00841036053734
• UDI-Public: (01)00841036053734(10)J327370
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121589
• 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
• Report Date (Section B): 01/07/2022

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 Catalogue Number: 91-6104
• Device Lot Number: J327370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• 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: 01/05/2022
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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