MAUDE Adverse Event Report: BIOMET MICROFIXATION ELEVATOR #301

Model Number N/A

Device Problems Bent (1059); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.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.This is report 4 of 5 for the same event.Reports 1-3, & 5 are reported on mfr #:0001032347-2016-00263 through 0001032347-2016-00265, and 0001032347-2016-00267.

Event Description

It was reported that six elevator #301's were broken and/or bent during different surgeries.There was no delay in any of the surgeries, all parts were retrieved in each case, and there was no injury to the patients.

Manufacturer Narrative

(b)(4).Review of the device history records show that the lot was released with no recorded anomaly or deviation.The product was returned for evaluation.According to the product evaluation, the complaint is confirmed as the tip of the elevator is slightly bent.The most-likely, underlying cause of the complaint was determined to be excessive force.The instructions for use states, "the tip of the instrument is extremely thin and delicate; care should be taken to avoid applying significant pressure to the tip." the non-conformance database was reviewed in the product evaluation and no non-conformances were found for this lot.There is no indication of manufacturing defects.This is report 5 of 6 for the same event.Reports 1, 2, 3, 4, and 6 are reported on mfr # 0001032347-2016-00230-2, 0001032347-2016-00263-1, 0001032347-2016-00264-1, 0001032347-2016-00265-1, and 0001032347-2016-00267-1.

• Brand Name: ELEVATOR #301
• Type of Device: ELEVATOR
• 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: 5694758
• MDR Text Key: 46404102
• Report Number: 0001032347-2016-00266
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

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 Model Number: N/A
• Device Catalogue Number: 09-0257
• Device Lot Number: 020515A15
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1