MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X25 ST; SCREW, FIXATION, BONE

Model Number N/A

Device Problems Fracture (1260); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product code - phx.(b)(4).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 mdr will be submitted.

Event Description

It was reported that during an initial reverse total shoulder arthroplasty, the surgeon tried to advance the screw into the glenoid's hard bone and sheared off the screw head while attempting to back it out, as it was difficult to advance the screw completely.The screw shaft was left in the patient.No additional patient consequences have been reported.No additional information is available from the event.

Manufacturer Narrative

The following report is being submitted to relay additional information received: the complaint cannot be confirmed as no medical records were provided.Review of device history records found these units were released to distribution with no deviations or anomalies.Root cause could not be determined.A summary of the investigation has been sent to the complainant.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 Description

No additional information is available to report.

• Brand Name: COMP LK SCR 3.5HEX 4.75X25 ST
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8399746
• MDR Text Key: 138112378
• Report Number: 0001825034-2019-00725
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 180552
• Device Lot Number: 371950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR