MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN SCREW INSTERTER/EXTRACTOR; KNEE INSTRUMENT

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.

Event Description

It was reported that the pin driver sheared off the head of the pin and it got stuck in it.Tibial guide bottom hole did not allow a pin to penetrate it.

Manufacturer Narrative

Concomitant medical products: nexgen head screw catalog # 00598304033 lot # 63865617.Multiple mdr reports were filled for this event: 0001822565 - 2018 - 01851.

Manufacturer Narrative

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

It was further reported when the surgeon pinned the femoral cut guide, the pin head sheared off within the driver.The surgeon then had to forcefully hammer the cutting block off of the patient's bone which resulted in the flat surface of the pin to fracture off.The fractured pieces of the pin were retrieved from the patient's wound.The surgeon then had to cut around the pin stuck in the patient's bone until he was able to grab and remove it with a vice grip.The pin driver was unusable as the head of the pin was stuck in the driver.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event is considered confirmed as visual examination showed the device's hex head fractured off and lodged in the inserter/extractor.Sem analysis relayed that it was suspected to be fractured due to overload.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: NEXGEN SCREW INSTERTER/EXTRACTOR
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7378598
• MDR Text Key: 103747784
• Report Number: 0001822565-2018-01789
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598304900
• Device Lot Number: 63880315
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 64