MAUDE Adverse Event Report: BIOMET MICROFIXATION RAPIDFLAP SPINDOWN CLAMP / 20 MM; BONE CLAMP

Model Number N/A

Device Problems Disassembly (1168); Fracture (1260); Shipping Damage or Problem (1570)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

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.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 that a rapidflap implant broke at the post during insertion.It is reported that there was no delay that exceeded thirty minutes and the patient did not retain a foreign body.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The part was visually evaluated and determined to be missing the applier.The rest of the product is fully intact and is functioning properly.The applier was not returned with the clamp.There is no visible damage of the post or clamp.It is unclear is the applier broke, or simply became disassembled.Dimensional evaluation was done on the post features that would interface with the applier.The thickness of the post where the applier is press fit onto is within specification.A micrometer was used to measure the diameter of the where the notch for the applier is cut out on; the part was within specification.The dhr (device history record) was reviewed and there are no indications of manufacturing defects.The most likely cause is force unintentionally applied to the applier during the shipping and handling process.Corrected lot number as it was inadvertently reported as 097920 and the correct lot is 094920.(b)(4).

• Brand Name: RAPIDFLAP SPINDOWN CLAMP / 20 MM
• Type of Device: BONE CLAMP
• 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: 5775177
• MDR Text Key: 48960369
• Report Number: 0001032347-2016-00333
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 75-1040
• Device Lot Number: 094920
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention