MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES INC SPEED TITAN 18X18X15MM IMPLANT, INSERTER; STAPLE, FIXATION, BONE

Catalog Number SE-181815TI

Device Problem Mechanical Jam (2983)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Patient age/date of birth and weight are unknown.Udi: (b)(4).Implant and explant dates: device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Two non-conformance reports were generated during production for se-181815ti.Relevance to complaint condition cannot be determined unless the product is returned for investigation.One addresses oversized sliders; upon rework, the sliders passed.The other concerns a slider that failed final inspection due misalignment on the stick.Review of the device history record(s) showed that there are potential 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 was reported that a speed titan staple would not release from the inserter during a tarsal-metatarsal (tmt) fusion of the second metatarsal.When the surgeon attempted to implant the staple, it would not release from the inserter.The surgeon pulled the inserter out and the staple sprung apart; it released from the inserter fully intact.A backup implant kit was available and the new insertion tool and new implant were used successfully.There was a reported approximate thirty (30) second surgical delay.The procedure was completed successfully with no patient harm.No additional information.Concomitant devices reported: staple (part unknown, lot unknown, quantity #1).This is report 1 of 1 for (b)(4).

• Brand Name: SPEED TITAN 18X18X15MM IMPLANT, INSERTER
• 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: mark vornheder ; 1302 wrights lange east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5939624
• MDR Text Key: 54412974
• Report Number: 1649263-2016-10000
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SE-181815TI
• Device Lot Number: BMESE160218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN STAPLE