MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2X320MM K-WIRE WITH TROCAR; PIN, FIXATION

Catalog Number 14-440052

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2019

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 a puncture on the outer package, penetrating the inner packaging, was found during receiving inspection.There was no patient involvement.

Manufacturer Narrative

Udi# (b)(4).The visual inspection of the returned product identified that the outer box and the sterile packaging had a hole punctured through, confirming the reported event.Review of the device history records identified no relevant deviations or anomalies.The root cause of the reported event is attributed to transit damage.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information received.

• Brand Name: 3.2X320MM K-WIRE WITH TROCAR
• Type of Device: PIN, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8289574
• MDR Text Key: 134496643
• Report Number: 0001825034-2019-00370
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K831005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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 Catalogue Number: 14-440052
• Device Lot Number: 710650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1