MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP LK SCR 3.5HEX 4.75X35 ST; SCREW, FIXATION, BONE

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

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.

Event Description

It was reported that during the surgery, the screw sterile packing seal was found to be not sealed completely.There was no patient impact as a result of the malfunction.No additional information is made available from this event.

Manufacturer Narrative

The following report is being submitted to relay additional information received.The visual inspection of the returned product identified that the sterile pouch was not sealed on one side.The reported event is confirmed.Review of the device history records for identified no deviations or anomalies.The root cause of the reported issue is attributed to operator error during the manufacturing process.Additional actions have been initiated through corrective action process.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 4.75X35 ST
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8370866
• MDR Text Key: 137264177
• Report Number: 0001825034-2019-00677
• Device Sequence Number: 1
• Product Code: KWS
• 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: 07/25/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 180554
• Device Lot Number: 142580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1