MAUDE Adverse Event Report: . ALPS LOW PROFILE CORTICAL SCREW; PLATE, FIXATION, BONE

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (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.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 the incoming inspection member found red debris in the sterile package.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product identified that there is red debris inside the sterile package.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a manufacturing deficiency.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: ALPS LOW PROFILE CORTICAL SCREW
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7487440
• MDR Text Key: 107696050
• Report Number: 0001825034-2018-03193
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/08/2018
• Device Model Number: N/A
• Device Catalogue Number: 851235032
• Device Lot Number: 451380
• Other Device ID Number: 00887868055171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1