MAUDE Adverse Event Report: BIOMET UK LTD. TINBN VG INT CR ANAT FM L 70M

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the inner packaging has been found broken.The surgery, which was a first implant, was completed with another device.The size of the device used to complete the surgery was smaller than the first device.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.(b)(4).

Event Description

It was reported that the inner packaging has been found broken.The surgery, which was a first implant, was completed with another device.The size of the device used to complete the surgery was smaller than the first device.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Visual inspection confirmed the reported event.The product left manufacturing site conforming to specifications according to the mhr review.The root cause of the reported event is likely to be transit damage.The item was in the field for approximately 6 years and 1 month.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: TINBN VG INT CR ANAT FM L 70M
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7532054
• MDR Text Key: 108851382
• Report Number: 3002806535-2018-00837
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

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 Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 183032TNBN
• Device Lot Number: 2595304
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 04/26/2018; 08/05/2019
• Supplement Dates FDA Received: 05/22/2018; 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1