MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. SURGICAL HOOD BS EN 166 Z 166 1F; GOWN, SURGICAL

Model Number N/A

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/28/2018

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 there was a loose particulate such as foreign substance which was found larger than 0.60 mm2.The issue was found at distributor inventory during inspection.  no adverse events were reported as a result of this malfunction.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

• Brand Name: SURGICAL HOOD BS EN 166 Z 166 1F
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7469926
• MDR Text Key: 107334067
• Report Number: 0001526350-2018-00372
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• PMA/PMN Number: PK132386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 00990030112
• Device Lot Number: D171293
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1