MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC UNK - END CAPS: TFNA; APPLIANCE, FIXATION, NAIL

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that in (b)(6) 2021, the patient underwent open reduction internal fixation surgery for trochanteric fracture of femur with tfna implants.Weight bearing started on the day after surgery.The postoperative course was confirmed by x-ray several times from the week after the surgery, and the course was favorable.But on (b)(6) 2021, it was found that the femoral head had turned inward, and the blade had cut through to pelvis.On (b)(6) 2021, tfna implants will be removed and the tha will be performed.No further information is available.This complaint involves four (4) devices.This report is for (1) unk - end caps: tfna.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - end caps: 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.Reporter is a j&j representative.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 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.

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.H6: health effect clinician code 2402 used to capture injury.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 - END CAPS: TFNA
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13118711
• MDR Text Key: 282976386
• Report Number: 8030965-2021-10562
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø11 130° L170 TIMO15; TFNA HELICAL BLADE PERF L85 TAN; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR