MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES INC SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM STAPLES; STAPLE,FIXATION,BONE

Catalog Number SE-1515TI

Device Problem Separation Failure (2547)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Date of surgery reported only as about one week prior to (b)(6) 2017 udi: (b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 was reported during a toe procedure about one week prior to (b)(6) 2017, the bme staple implant did not deploy from the bme insertion mechanism properly.Another bme staple implant and insertion mechanism device was readily available and was used to complete the procedure successfully with a delay of approximately one (1) minute while the second device package was opened.This report is for one (1) speedtitan compression implant kit.This is report 1 of 1 for (b)(4).

• Brand Name: SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM STAPLES
• Type of Device: STAPLE,FIXATION,BONE
• Manufacturer (Section D): BIO MEDICAL ENTERPRISES INC; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer (Section G): BIO MEDICAL ENTERPRISES INC; 14785 omicron dr # 205; san antonio TX 78245
• Manufacturer Contact: michael cote ; 1302 wrights lange east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6591510
• MDR Text Key: 76049971
• Report Number: 1649263-2017-10009
• 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: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SE-1515TI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1