MAUDE Adverse Event Report: BIOMET MICROFIXATION SPIN DOWN RAPIDFLAP; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE, RAPIDFLAP SPINDOWN CLAMP 12MM

Model Number N/A

Device Problems Disassembly (1168); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A photograph was provided of the device which shows the applier is no longer attached to the clamp.Review of device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.Without a product return, no product evaluation is able to be conducted.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported the applier fractured before the clamp could be closed completely during a cranial procedure.Additional details were requested but have not been received at this time.

Manufacturer Narrative

Were updated based on the receipt of the device for evaluation.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was visually evaluated and found to have the applier removed from the post.The applier can be placed back onto the post and used to rotate the plate as intended.Review of the complaint history determined that no further action is required as no trends were identified.Investigation results concluded that the reported event was due to general handling of the device.The instructions for use (ifu) for this product states in the warnings section: ¿correct handling of implants is extremely important.Do not modify implants.Do not notch or bend implants.Notches or scratches put in the implant during the course of surgery may contribute to breakage.¿ 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.The following sections were updated: date of this report, date received by manufacturer, type of report and follow-up number, follow-up type, device evaluated by manufacturer.Additional narratives/data.

• Brand Name: SPIN DOWN RAPIDFLAP
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE, RAPIDFLAP SPINDOWN CLAMP 12MM
• 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: 6859455
• MDR Text Key: 85829156
• Report Number: 0001032347-2017-00714
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK031034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 75-1020-12
• Device Lot Number: 768220
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention