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

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of the device history records shows the lot was released with no recorded anomaly or deviation.The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.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 outer plate would not rotate during a surgery.The position was noted as "cranial." the patient did not retain a foreign body.The surgery was completed using a new rapid flap clamp.The event resulted in a delay that was less than ten minutes.

Manufacturer Narrative

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 not confirmed.The returned device was evaluated for the complaint that the outer plate did not rotate during a surgery.Upon evaluation the outer plate rotates easily through the threaded section and becomes difficult to rotate through the crimped section, as intended; therefore, the complaint was unconfirmed.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 the surgeon attempting to rotate the outer plate through the crimped section of the post.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.

• Brand Name: RAPIDFLAP SPINDOWN CLAMP 12 MM 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: 6754295
• MDR Text Key: 81413624
• Report Number: 0001032347-2017-00603
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2020
• Device Model Number: N/A
• Device Catalogue Number: 75-1020-12
• Device Lot Number: 381140
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention