MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROXIMAL NAIL EXTRACTOR BOLT; TRAUMA INSTRUMENTATION

Catalog Number 281018010

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: 0001825034-2019-01789.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) review was unable to be performed as the lot number of the device involved in the event is unknown.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001825034- 2019- 01974.Item# 181709241, lot# m01043, item name: universal hum nail 9x240mm.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

• Brand Name: PROXIMAL NAIL EXTRACTOR BOLT
• Type of Device: TRAUMA INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8535784
• MDR Text Key: 142627895
• Report Number: 0001825034-2019-01787
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 281018010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/22/2019
• Supplement Dates Manufacturer Received: 04/26/2019; 10/22/2019
• Supplement Dates FDA Received: 05/01/2019; 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention