MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES INC SPEED TITAN 15X15X15MM IMPLANT; BONE STAPLE

Catalog Number SE-1515TI

Device Problem Failure to Advance (2524)

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

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

Patient weight is unknown.Udi: (b)(4).Implant and explant dates: device is a combined implant and its instrument.Due to intra-operative issues, the implant device was not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as it was reportedly discarded by the facility.Part se-1515ti, bme lot bmese160119: manufacturing date or release to warehouse date: april 15, 2016.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported during a triple arthrodesis of the left foot, the speed titan staple would not release from the inserter.A second implant kit was readily available and surgeon again attempted to place the staple.The staple from the second device also would not release from the inserter.Surgeon then chose to implant a plate system instead.Surgery was completed successfully with a fifteen (15) minute delay and no harm to patient.This is report 2 of 2 for (b)(4).

• Brand Name: SPEED TITAN 15X15X15MM IMPLANT
• Type of Device: BONE STAPLE
• Manufacturer (Section D): BIO MEDICAL ENTERPRISES INC; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer Contact: mark vornheder ; 1302 wrights lange east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6128987
• MDR Text Key: 60944367
• Report Number: 1649263-2016-10003
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SE-1515TI
• Device Lot Number: BMESE160119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR