MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA; ROD, FIXATION, INTRAMEDULLARY

Catalog Number UNK - NAILS: TFNA

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: this report is for an unknown nails: tfna/unknown lot.Part and lot numbers are unknown; udi 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.Product was not returned.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the (b)(6) as follows: it was reported that on an unknown date, the nail broke at the lag screw interface and the patient went to or for removal of a broken intermediate tfna nail.The patient also had a total hip done at this time as they had a nonunion of the fracture.There was a patient and procedure involvement.Concomitant devices reported: unk - screws: nail distal locking (part # unknown, lot # unknown, quantity 1) unk - screws: trauma (part # unknown, lot # unknown, quantity 1) unk - end caps: tfna (part # unknown, lot # unknown, quantity 1) unk - nail head elem: tfna lag screw (part # unknown, lot # unknown, quantity 1) this complaint involves one (1) device unk - nails: tfna.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - NAILS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14270264
• MDR Text Key: 290787612
• Report Number: 2939274-2022-01579
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2022

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 Catalogue Number: UNK - NAILS: TFNA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEM: TFNA LAG SCREW; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention