MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; INTRAMEDULLARY BONE FASTENER

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is unknown.This report is for one (1) unknown bme implant.Part#, lot# and udi # is not available.Implanted date: unknown.Explanted date: unknown.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown bme implant.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 an unknown hammer lock bme implant broke in situ during the implant procedure.Original implant information is unknown.Surgical plan and procedure are unknown.Concomitant device reported: plate (part # unknown, lot # unknown, quantity unknown).This report is for one (1) unknown bme implant.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

510k: this report is for one (1) unknown bme bone staple: hammerlock 2/unknown lot.Part and lot number are unknown; udi number is unknown.510-k number is unknown.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

Further it was clarified that a patient underwent the foot surgery and was implanted with an unknown hammer lock bme implant on an unknown date.On an unknown postoperative date a hammer lock bme implant broke in situ.This report is for one (1) unknown bone staple: hammerlock 2.

Event Description

It was further reported that the patient will be scheduled for a removal of the broken implanted unknown hammer lock bme.Hardware removal schedule is unknown.

Manufacturer Narrative

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.

• Type of Device: INTRAMEDULLARY BONE FASTENER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7802202
• MDR Text Key: 117769449
• Report Number: 2939274-2018-53414
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 09/25/2018
• Supplement Dates FDA Received: 09/20/2018; 09/25/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention