MAUDE Adverse Event Report: BIOMET MICROFIXATION RAPIDFLAP (TM) SYSTEM 16 MM RAPIDFLAP SPINDOWN CLAMP, 12 PACK; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign country: (b)(6).Complaint sample was evaluated and the reported event was confirmed.The product identity was confirmed.The complaint is that the outer plate was off from the body after the post was tightened.The rapidflap (tm) system 16 mm rapidflap spindown clamp (part# 75-1030, lot# 281940) was visually evaluated.All parts of the clamp assembly were returned and also an additional applier.The clamp showed signs of significant use.The inner clamp had a few scratches near the edge.The post was found to be broken in two places: near the bottom of the threaded portion by the inner clamp and at the top of the post where the applier fits on.The post was also bent near each area where it fractured.The tip of the post where the applier fits on was fractured off and stuck inside the through hole of the applier.The tapered nut also appeared to be spun down on the post in the inverted orientation.The device history record (dhr) was reviewed for these products and no non-conformances were noted.However, the nut inversion issue is a known nonconformance.Investigation results concluded that the underlying cause of the bending and fracturing is mishandling by the customer.Investigation results concluded that the underlying cause of the outer plate being off the post is the inverted nut, which is a result of shipping of a product that was assembled incorrectly.There are no additional indications of manufacturing defects.The instructions for use (ifu) for this product states in the section titled description: the devices are assembled by rotating the outer plate to contact the cranial bone then rotating the applier which forces the plates together capturing the cranial bone.When applied, the plates tightly grip the bone flap, and provide rigid attachment and coplanar alignment to the surrounding bone.Removal of the residual post after clamp application may be performed by either shearing the post in a cantilevered fashion manually or using the rapidflap¿ cutter.A summary of the investigation has been sent to the complainant.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 reported the outer plate was off from the body after post tighten during a craniotomy.Alternative spindown product of the same size was used to finalize the surgery.No additional patient consequences were reported.

• Brand Name: RAPIDFLAP (TM) SYSTEM 16 MM RAPIDFLAP SPINDOWN CLAMP, 12 PACK
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 8231062
• MDR Text Key: 132505780
• Report Number: 0001032347-2019-00025
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 75-1030-12
• Device Lot Number: 281940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention