MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.205S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

Udi number unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.

Event Description

It was reported that on an unknown date, it was notified by the surgeon that the tfna patient was missed the helical blade nail.The nail revised several days later.The patient now has arthritis of the hip and possible infection of the old surgical area.The surgeon recommended for additional surgery to clear up the infection, removal of the tfna hardware and possible total hip arthroplasty.The patient was in adverse conditions.This complaint involves unknown number of devices.This report is for (1) unk -nail head elements: tfna helical blade.This is report 3 of 3 (b)(4).Related product complaint: (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.H10 additional narrative: b5 d6a, d6b g1: manufacturing site name and address h4 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 on an unknown date, a patients received a tfna nail and it was noticed, post-op, that the helical blade missed the nail.The initial surgery was performed on (b)(6) 2021.The nail was revised several days later.The patient¿s fracture was healing but the patient was experiencing arthritis of the hip and possible infection of the old surgical area.On (b)(6) 2021 the nail, lag screw, and two (2) screws were removed with no complications or additional time needed.Patient status is unknown.This is report 3 of 4 (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.D2: additional pro-code: ktt.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot : 17-feb-2021 a dhr review was not performed for this pi.This lot was manufactured by elmira.Please reassign this task to the correct group.22-feb-2021.Part number: 04.038m205sp.Lot number: 39p4689.Part manufacture date: 29-jan-2020.Manufacturing location: elmira.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated screw 105mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot was shipped to monument and assigned as part number 04.038.205s for final packaging.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history batch null, device history review 17-feb-2021: dhr reviewed.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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: TFNA FENESTRATED SCREW 105MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11334879
• MDR Text Key: 232167738
• Report Number: 2939274-2021-00891
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.205S
• Device Lot Number: 39P4689
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø14 R 130° L420 TIMO15; TFNA FENESTRATED SCREW 105MM - STERILE; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA; UNK - SCREWS: 5.0 MM CANNULATED; UNK - SCREWS: 5.0 MM CANNULATED; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR