MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB 14 MM RAPIDFLAP CLAMP; LACTOSORB CLAMP

Model Number N/A

Device Problems Device Inoperable (1663); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.Based on the evaluation, the complaint was confirmed.The most-likely, underlying cause was determined to be due to deflection of the material during tooling (manufacturing process).In the evaluation, the implant was functionally tested by moving the outer plate up and down along the post.During this test it was found that the outer plate became difficult to move in one section of the post.The post was evaluated and it was found that the threads causing the outer plate to stick were wider than the other threads.It was found that the major and minor diameters were too large.The device history records were reviewed and no-non-conformances were noted.

Event Description

It was reported that 9 rapidflap clamp caps were very difficult to turn and didn't close.It was reported that no delay in the surgeries associated with this problem occurred and no patient injury resulted.

• Brand Name: LACTOSORB 14 MM RAPIDFLAP CLAMP
• Type of Device: LACTOSORB 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: 5761876
• MDR Text Key: 48554733
• Report Number: 0001032347-2016-00316
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK003281
• 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
• Report Date: 04/01/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 915-0020
• Device Lot Number: 362270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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