SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.037.056S |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Pain (1994)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent an unknown surgery with the tfna nail and the tfna blade.In early (b)(6), significant displacement of the blade was confirmed by postoperative x-rays.The patient did not complain of pain, so that the surgeon decided to follow up with the patient for observation.On the end of (b)(6) 2022, cut-out was confirmed by x-rays.The patient complained of pain, so a revision surgery was planned.Preoperative x-rays on (b)(6) 2022, showed only a slight cut-out of the tip of the blade in femoral head.However, by preoperative x-rays on (b)(6) 2022, the day of the revision surgery, the blade had displaced further and cut through the pelvis.There were concerns about the failure of the locking mechanism, and the sales rep suggested replacing the nail.However, since the patient had a medical history of heart failure and intraoperative confirmation determined that there was no failure of the locking mechanism, the surgery was completed with the replacement of the 75mm blade.It was confirmed by x-rays that there were no fragments in the patient¿s body.According to the surgeon, the patient has osteoporosis, and the bone is very fragile and shortened excessively.It caused the cut-out in femoral head.The physiotherapist reported the patient was not under excessive load, so that the exact cause for the cut-out in femoral head is unknown.This is report 1 of 2 for (b)(4).This complaint is for tfna nail.
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Manufacturer Narrative
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Unknown when screws broke.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative 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.
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Manufacturer Narrative
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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.H4 device history part #: 04.037.056s, lot #: 9963969, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 08 dec 2015, expiration date: 01 dec 2025.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
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