MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES INC HAMMERLOCK2 IMPLANT 15X5 MM STRAIGHT; INTRAMEDULLARY BONE FASTENER

Catalog Number HL2M

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Udi: (b)(4).Device has not been 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 that a hammerlock implant ii failed after being implanted on (b)(6) 2017.On an unknown date, postoperatively the implant reportedly ¿popped out of place¿.It was further explained the implant popped out of the desired implant site and the patient¿s skin.The patient was reported to have a severe deformity of an unknown toe and it was thought that the implant could not ¿handle it¿.The patient is reportedly at home, is stable, and not experiencing any pain.The revision surgery has not yet occurred but will be scheduled in the near future; the surgeon is deciding on a surgical date.There were no reports of an injury, fall, or infection.This report is for one (1) hammerlock ii implant this is report 1 of 1 for (b)(4).

• Brand Name: HAMMERLOCK2 IMPLANT 15X5 MM STRAIGHT
• Type of Device: INTRAMEDULLARY BONE FASTENER
• 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: 6653971
• MDR Text Key: 78019353
• Report Number: 1649263-2017-10013
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HL2M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention