MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISCOVERY PROVISIONAL LOCK SCREW; TEMPLATE

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

(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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04589, 0001825034 - 2018 - 04655.Not yet returned.

Event Description

It was reported that during a revision elbow arthroplasty, following trialing of the components, the surgeon tried to remove a lock screw with a driver but the screw did not release despite trying repeatedly.Eventually, the ulnar trial and humeral trial were forcibly pulled in greater flexion position, which resulted in the patient's bone fracturing.The fracture was fixed with a wire and the procedure was successfully completed.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of product returned.Per visual inspection, the product is at least 8 years old and show severe signs of wear.It is confirmed that the one screw that is installed does not come out of the instrument.Dhr could not be reviewed as product identification is not known.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A summary of the investigation has been sent to the complainant.Investigation and root cause remained unchanged.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 further event information is available at the time of this report.

• Brand Name: DISCOVERY PROVISIONAL LOCK SCREW
• Type of Device: TEMPLATE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7781329
• MDR Text Key: 117121592
• Report Number: 0001825034-2018-04590
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• 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: 414806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 414845,DISC 3.5X124MM RIGHT HUM TRIAL, UNKNOWN; 414885, DISC 2.5X84MM RIGHT ULNA TRIAL, 836410; 414897,XS CONDYLE PROV MALE/FEMALE, 116310
• Patient Outcome(s): Required Intervention