MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW SQ 2.7MM 20MM STE; APPLIANCE, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign ¿ events occurred in (b)(6).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 the screw was implanted into the patient's bone and would not lock and had to be removed.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The reported event could not be confirmed as the product was not returned.Dhr was reviewed and no discrepancies were found.Without the opportunity to examine the complaint product, 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.

Event Description

It was reported that after multiple attempts the surgeon was unable to get the screw to lock into the plate.The operation was completed using another screw after a delay of 15 minutes.No further information has been made available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was returned for evaluation.As returned, the screw exhibited minor cosmetic damage.Additionally the locking threads on the head appear to be damaged.No dimensional analysis was conducted due to the damage.The complaint is confirmed based on the damage to the threads.Dhr was reviewed and no discrepancies were found.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.

• Brand Name: LOCK SCREW SQ 2.7MM 20MM STE
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7064077
• MDR Text Key: 93108774
• Report Number: 0001825034-2017-10334
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: PK112345
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 131827120
• Device Lot Number: 337010
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Date Manufacturer Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention