MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: DHS/DCS; NAIL, FIXATION, BONE

Device Problems Device Difficult to Maintain (3134); Patient Device Interaction Problem (4001)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2019

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown nail head elem: dhs/dcs lag screw/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.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 as no product was received.The investigation could not be completed; no conclusion could be drawn.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) of femur.During the procedure, the dynamic hip and condylar screw system (dhs/dcs) plate would not fit over a one (1) (dhs/dcs) guide shaft.For this reason, the doctor manipulated one (1) connecting screw which caused bending in the connecting screw and having to resort using another (dhs/dcs) tray and implant to discover the issue.The doctor was unable to fix the implant to the bone.The doctor asked for an additional intraoperative x-ray to determine if there was something wrong with the area the doctor reamed in the femoral head.The doctor wanted to determine why the issue was occurring.The procedure outcome was unknown with a thirty (30) minutes surgical delay.There was no patient consequence.Concomitant device reported: unknown (dhs/dcs) plate (part# unknown, lot# unknown, quantity# 1).This complaint involves two (2) devices.This report is for one (1) unk - nail head elem: dhs/dcs lag screw.This report is 1 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Concomitant device was reported inadvertently on the initial medwatch report.There is no concomitant device associated with this report.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.

• Brand Name: UNK - NAIL HEAD ELEM: DHS/DCS
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8735031
• MDR Text Key: 149219252
• Report Number: 2939274-2019-58842
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 08/21/2019
• Patient Sequence Number: 1