MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIVERSAL HUM NAIL 9X240MM; TRAUMA IMPLANT

Catalog Number 181709241

Device Problem Difficult to Insert (1316)

Patient Problem Blood Loss (2597)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01787 item# 281018010, item name: proximal nail extractor bolt lot# unk, 0001825034 - 2019 - 01789 item# 281017022, item name: universal nail extractor bolt lot# unk.Product not returned.

Event Description

It was reported that during the surgery the extractor does not assemble with the nail.Steel wire was used to extract the nail.Surgery time was increased with blood loss.No further event related information available at the time of this report.

Manufacturer Narrative

Reported event was confirmed by review of radiographs and medical records.Device history record (dhr) was reviewed and no discrepancies were found.Review of the medical records identified that the revision procedure was due to a rotator cuff tear and there are no allegations against the nail (it was a routine removal).During the procedure, a steel cable had to be used in order to remove the nail.The rotator cuff was repaired with suture.As it is unknown which extractor bolt was used in the procedure, the definitive root cause was unable to be determined.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: UNIVERSAL HUM NAIL 9X240MM
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8568450
• MDR Text Key: 143667005
• Report Number: 0001825034-2019-01974
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K033878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 181709241
• Device Lot Number: M01043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention