MAUDE Adverse Event Report: BIOMET MICROFIXATION RAPIDFLAP (TM) SYSTEM 12MM RAPIDFLAP SPINDOWN CLAMP12MM X 32MM; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported the clamp fractured during a procedure.The procedure was completed using other clamps.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The rf spindown clamp 12mm (item# 75-1020, lot# 486410) was returned for investigation.The clamp showed clear signs of use, with the post fractured near the t-handle.The fracture occurred on the smooth section of the post, opposed to the threaded section and was located near the step change.The clamp was returned with the outer plate spun almost all the way down onto the post, near the bottom inner plate.This is indicative that the plates were likely clamped down on the patient's bone.The dhr was reviewed for this product; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this item# 75-1020, lot# 486410.The most likely underlying cause of the fracture is excessive force during application, beyond what the device was designed to encounter.It is possible that this was due to over-torqueing or off-axis force application.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report b5 describe event or problem d4 expiration date d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h4 device manufacturer date h6 method code h6 results code h6 conclusions code h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: RAPIDFLAP (TM) SYSTEM 12MM RAPIDFLAP SPINDOWN CLAMP12MM X 32MM
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10320800
• Report Number: 0001032347-2020-00327
• Device Sequence Number: 14197857
• Product Code: GXN
• UDI-Device Identifier: 00841036058586
• UDI-Public: 00841036058586
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: N/A
• Device Catalogue Number: 75-1020
• Device Lot Number: 486410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1