MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES INC SPEEDTRIAD COMPRESSION IMPLANT KIT 18X15X8MM CENTERED; STAPLE,FIXATION,BONE

Catalog Number SE-181508TRC

Device Problem Failure to Advance (2524)

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

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

Patient age, date of birth, and weight not available for reporting.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review, part number: se-181508trc, bme lot number: bse170313, lot expiration date: 17 may 2022, manufacturing date or release to warehouse date: 8 june 2017/ no ncmrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Nc, no relevance to complaint condition.Dhr review (parent lot), part number: se-181508trc, bme lot number: 1701127037, manufacturing date or release to warehouse date: 3 may 2017.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.Nc, no relevance to complaint condition.Dhr review (parent lot), part number: se- 181508trc, bme lot number: 1703127126, manufacturing date or release to warehouse date: 12 april 2017.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.Nc, no relevance to complaint condition.Dhr review (parent lot), part number: se-181508trc, bme lot number: 1703127138, manufacturing date or release to warehouse date: 20 april 2017.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.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 during a right chevron bunionectomy a triage bme staple would not seat properly in the patient bone.The staple was one quarter of an inch prominent.The device had to removed, the bone was re-drilled and a second staple was implanted without issue.Reportedly the surgeon re-drilled in the same location (perhaps a bit deeper) and the second staple was implanted without an issue; it worked just fine.There was a 2-3 minute delay in the surgery due to the device malfunction; the time it took to retrieve and open another staple.There were no further intraoperative events, the surgery was successfully completed with no harm to the patient.The patient was reported to be stable at the end of the procedure.The complained device was discarded and is not available for investigation.This report is for one (1) speedtriad compression implant kit.This is report 1 of 1 for (b)(4).

• Brand Name: SPEEDTRIAD COMPRESSION IMPLANT KIT 18X15X8MM CENTERED
• Type of Device: STAPLE,FIXATION,BONE
• Manufacturer (Section D): 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: 7022573
• MDR Text Key: 92729495
• Report Number: 1649263-2017-10021
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133844
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: SE-181508TRC
• Device Lot Number: BSE170313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1