MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE LOC SCREW; FASTENER, FIXATION

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.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 during the implantation of a vrs custom glenoid baseplate, one of the comprehensive fixed locking screws became locked into the bone and was unable to be removed or advanced without stripping the screw head.It was a 45 mm screw, and approximately 5 mm of it was sticking out of the implant when it locked in place.Multiple zimmer biomet screw drivers were used to remove the screw, as well as a needle nose vice grip.Ultimately a trephine style removal tool successfully unlocked and removed the screw.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4), reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Additional Manufacturer Narrative
(b)(4).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: COMPREHENSIVE LOC SCREW
• Common Device Name: FASTENER, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10101615
• Report Number: 0001825034-2020-02148
• Device Sequence Number: 11533818
• Product Code: KWS
• UDI-Device Identifier: 00880304677197
• UDI-Public: (01)00880304677197
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2021

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: 180556
• Device Lot Number: 874180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 10/02/2020; 09/28/2021
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 10/06/2020; 10/21/2021
• 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
• Patient Age: 78 YR