MAUDE Adverse Event Report: BIOMET 3I ANALOG IMP 3.5MM IMP 2.5M M HEX

Catalog Number IA3

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient information not provided/unknown.Event date not provided/unknown.

Event Description

It was reported that when retrieving the analog, it was missing from the package.No patient involvement indicated.

Manufacturer Narrative

One analog packaging was returned for investigation.Visual evaluation of the as returned product identified a sealed and intact packaging with only the ifu inside.The packaging was missing the device.A device history review was performed and no related nonconformance¿s were noted.A complaint history search was performed using our complaint handling system and there were no additional related complaints against this lot.Appropriate documentation was reviewed.Additionally, the dhr for lot 2019032042 was further reviewed and the following documents have been attached regarding the device verification and pick list.A quantity on-hand review was performed for the reported lot number (2019032042) and it was determined all the devices in the lot have been distributed.The size of the lot was (b)(4) devices.The alleged device malfunction was confirmed.A root cause cannot be determined.An ie has been initiated to address the packaging issue.The following sections have been updated: b4: date of this report d4: device expiration is n/a.D4: udi.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H4: date of manufacture.H6: entered evaluation codes.H10: added manufacturer narrative.

Event Description

No further event information available at the time of this report.

• Brand Name: ANALOG IMP 3.5MM IMP 2.5M M HEX
• Type of Device: ANALOG
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9860612
• MDR Text Key: 184309346
• Report Number: 0001038806-2020-00540
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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 Catalogue Number: IA3
• Device Lot Number: 2019032042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 05/22/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1