MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 12 MM DIAMETER 40 CM LENGTH; NAIL, FIXATION

Model Number N/A

Device Problems Device Markings/Labelling Problem (2911); Device Packaging Compromised (2916)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - the event occurred in (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.

Event Description

It was reported that the nurse opened a 12 x 40 tibial nail.It was observed prior to implantation that the nail was actually an 8.3 x 34 tibial nail.Both the packaging and the stickers said 12 x 40.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

A previous medwatch indicated that mdr 0001822565-2019-01425 would also be sent related to this event.However, 0001822565-2019-01425 will not be sent.

Event Description

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

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02967 and 0001822565-2019-01425.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product confirmed that the labels had item #47249540012 lot #62894912r printed on them whereas the package contained item #47249534008 lot #61169228.Device history record was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to a deviation in the labeling process, attributed to human error.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

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

• Brand Name: TIBIAL NAIL - YELLOW 12 MM DIAMETER 40 CM LENGTH
• Type of Device: NAIL, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7565043
• MDR Text Key: 109909128
• Report Number: 0001822565-2018-02967
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: PK082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 47249540012
• Device Lot Number: 62894912R
• Other Device ID Number: (01) 00889024097803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 04/08/2019; 04/08/2019
• Supplement Dates FDA Received: 04/08/2019; 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1