MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X4MM X-DRIVE TF SD SCREW EA; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the tumor extraction procedure in the cranium, the screw could not be gripped.The procedure was completed using an alternative screw, with a surgical delay under ten (10) minutes.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is unconfirmed.The screw appeared to be in good condition overall.Functional testing was conducted for retention using a driver (part# 46-0008) and blade (part# 15-1196).The blade was inserted into the driver and the screw, then the assembly was lifted by the screw to verify the cross-drive feature could support the weight of the blade and driver.The screw passed this retention test.The dhr for this screw could not be reviewed due to the lot number being unknown.There are no indications of manufacturing defects.For this part (91-6704) and the previous one year (from the notification date), there is a complaint rate of 0.020%, which is below the occurrence rate of this failure mode.The most likely underlying cause of the complaint cannot be determined.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
This follow-up report is being submitted to relay additional information.

• Brand Name: 1.5X4MM X-DRIVE TF SD SCREW EA
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8700331
• Report Number: 0001032347-2019-00327
• Device Sequence Number: 2308961
• Product Code: JEY
• UDI-Device Identifier: 00841036134808
• UDI-Public: 00841036134808
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 91-6704
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 08/25/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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