MAUDE Adverse Event Report: BIO MEDICAL ENTERPRISES INC HAMMERLOCK 2 IMPLANT KIT 15X5MM/10 DEGREES/MEDIUM, IMPLANT; INTRAMEDULLARY BONE FASTENER

Catalog Number HL2MA

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Implant and explant dates: due to intra-operative issues, the 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.(b)(4).Part hl2ma, bme lot bhl170033 (parent lots 1610125292 and 161125329): manufacturing date or release to warehouse date: march 08, 2017.Expiration date: february 01, 2022.No non-conformance reports relevant to the complaint condition 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.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 patient had an initial procedure on (b)(6) 2017 on the left foot second metatarsal due to the patient presenting with a hammer toe.During this procedure, the surgeon implanted the hammerlock 2 medium implant into the patient's medullary metatarsal bone.This medium implant was not large enough to correct the patient's bone deformity.The size large hammerlock 2 implant was ordered, but the implant was on back-order.The larger size implant was not available in this procedure for the surgeon to use.Again, during this procedure on (b)(6) 2017 the medium sized implant was removed and patient was implanted with a headless compression screw to correct the hammer toe.Due to this issue, there was a fifteen (15) minute surgical delay to remove the implant and revise the patient to a screw implant.Additional images were taken.The surgery was successfully completed and the patient was reported in stable condition.Concomitant device: hammerlock 2 drill kit (part dk-h2, lot bdk170010, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: HAMMERLOCK 2 IMPLANT KIT 15X5MM/10 DEGREES/MEDIUM, IMPLANT
• Type of Device: INTRAMEDULLARY BONE FASTENER
• 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: 6711909
• MDR Text Key: 80007902
• Report Number: 1649263-2017-10014
• 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: Other
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: HL2MA
• Device Lot Number: BHL170033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR