MAUDE Adverse Event Report: SYNTHES (USA), LLC FEMORAL NAIL KIT; DEVICE, FIXATION, PROXIMAL FEMORAL,

Device Problems Break (1069); Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problems Emotional Changes (1831); Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Date 12/15/2022

Event Description

Product: depuy synthes femoral nail kit.The complainant is a 49 y/o man with pre-diagnosed prostate cancer.On (b)(6) 2022, he broke his right femur and experienced great pain.On (b)(6) 2022, dr.(b)(6) orthopedic surgeon, (b)(6), surgically implanted this nail kit in the complainant's right leg, and he was released on (b)(6) 2022 and recovered at home for the next 8 weeks in which he participated in a stringent physical therapy program, with 29 of 30 outpatient appointments and exercises at home per instructions provided by the pt staff.He had been advised that there were no limits on what he could do within reason.He had some groin pain residual at that time.Dr.(b)(6) gave him an xray on (b)(6) 2022, and was advised that everything looked fine and that they would see him in a year.On (b)(6) 2022, the pain in his groin, and whole right leg and hip became so excruciating that he had to crawl to his car due to the pain and had to use a luggage cart to roll himself to the hotel room that he was staying.On 12/16/2022, he felt that his whole right leg was not stable.On (b)(6) 2022, went to (b)(6) where a doctor advised him that the x-ray disclosed fracture and damage to his right leg, and the device rod looked crooked, "like a hockey stick".He was treated with morphine.The hospital took him by ambulance to (b)(6) where he was admitted on (b)(6) 2022.On (b)(6) 2022, dr.(b)(6) removed the broken parts of the depuy synthes femoral nail kit and inserted a replacement depuy synthes femoral nail kit.He was advised that he had fractures down his right leg.He was released on (b)(6) 2022.He was treated with oxycodone, dilaudid, and tylenol pm.He was advised that if something happens to his leg again, his leg itself would be at risk.The complainant believes that the faulty/broken nail kit caused the additional fractures, excruciating pain, and mental anguish.The complainant notified depuy/j&j, who filed an mdr with the fda (b)(4) nurse, (b)(4).He stated that the firm was dismissive, rude, and hung-up.He asked the surgeon's office for the broken device and they told him they threw it away and could not obtain lot codes and exp dates.He was provided with foia.Firm's responses continued from pg.2 of this cc (init disp remarks): q: has your firm received any similar complaints? a.There was one similar incident received from japan for product 14/130 deg ti cann tfna 380/right-sile (catalog # 04.037.458s) for reported issue of broken post-operatively in year 2019.There are no similar incidents received for product 14/130 deg ti cann tfna 380/right-sile (catalog # 04.037.458s) for reported issue of broken post-operatively for years 2020, 2021, 2022 and 2023.Q.Your response to this complaint: the reported information reasonably suggests that one of the company's devices may have caused or contributed to a serious injury.This complaint was reviewed and has been determined as reportable to fda based on the product problem broken postoperatively and patient codes pain, fracture, medical device removal and surgical intervention.The reports for this complaint have been submitted under manufacturer's report number 2939274-2023-00006.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 and depuy synthes will report accordingly".Injury/illness: pain in groin, right leg, and hip; fractures down right leg; unstable right leg, mental anguish.Ref report: 2939274-2023-00006.

• Brand Name: FEMORAL NAIL KIT
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL,
• Manufacturer (Section D): SYNTHES (USA), LLC
• MDR Report Key: 16514927
• MDR Text Key: 311046101
• Report Number: MW5115617
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: BLADE HELICAL 95MM; NAIL BONE 14MM; SCREW BONE 50X5.0MM; SCREW BONE 60X5.0MM