Product complaint #: (b)(4).510k: this report is for an unknown constructs: pfna/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.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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Device report from synthes (b)(4) reports an event in czech republic as follows: this report is being filed after the review of the following journal article: pavelka, t.And salá¿ek, m.(2020), treatment of sub trochanteric fractures, our experience, complications, acta chirurgiae orthopaedicae et traumatologiae cechoslovaca, vol 87 (4), pages 259-267 (czech republic).The aim of this retrospective study is to assess the outcomes of surgical treatment in patients who sustained a sub trochanteric fracture.Between 2010 to 2018, a total of 118 patients (75 male and 43 female) with mean age of 61 years (19-91) were included in the study.Synthes implants were used for osteosynthesis: pfn a long in 95 patients, pfn a in 11 patients and lfn in 12 patients.X-rays were done in the anteroposterior and lateral projections after the surgery, then after 6 weeks, and after 3, 6, 9, and 12 months postoperatively.In case of impaired healing and need for revision surgery, follow-up until complete healing was achieved.The mean follow-up period was unknown.The following complications were reported as follows: 19 patients reported occasional mild pain after weight-bearing.In 65 patients, a limited rotation by 1/3 was found on examination.In 9 patients, a limited rotation up to 1/2 was found.In 15 patients, perioperative complications were recorded.13 patients had an imperfect reduction with persistent varus or flexion deformity or combination of both dislocations.In all cases, the angle deviation was associated with incorrectly inserted implant.2 patients had a revision surgery due to incorrect position within 2 weeks.In 11 cases, this error manifested as impaired healing with necessary revision surgery.Early replacement of interlocking screws was required in 2 patients (1%) in order to secure joint distraction.2 patients had hematoma in the wound (early postoperative complications) which required revision.11 patients (6 men, 5 women) had an impaired bone healing with formation of a false joint (late complications) which required total of 28 surgeries.Impaired healing analysis showed that it was associated with complete failure of the implant in 4 cases, in 3 cases with nail auto-dynamization only.Varus deformity after reduction in the range of 10-16° was found in 5 patients, flexion deformity in the range of 10-18° in 3 patients, and 3 patients had anteroposterior as well as lateral dislocation.A (b)(6) year-old male patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old male patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old male patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old female patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old female patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old female patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old male patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old male patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old male patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old female patient underwent a revision surgery for an impaired bone healing with formation of a false joint.A (b)(6) year-old female patient underwent a revision surgery for an impaired bone healing with formation of a false joint.In a (b)(6) year-old male patient, x-ray after 16 weeks showed failing osteosynthesis and underwent revision osteosynthesis with spongioplasty (fig.4).A (b)(6) year-old female patient had an unsuccessful reduction and persistent displacement.A revision surgery with nail removal, reduction supported by cerclage wires and insertion of the nail into correct position was performed (fig.6).A (b)(6) year-old female patient had varus position persisted in the proximal part of subtrochanteric region and nonunion is formed after reduction and underwent revision surgery using a plate.At 28 months after the surgery and 6 months after the revision surgery using pfn a long nail, nonunion unhealed, varus displacement persists (fig.7).This report is for an unknown synthes pfna constructs, unknown synthes pfna long constructs, and unknown synthes lfn constructs.Pc- (b)(4) ¿ this complaint will include 10 devices ¿ 2 unk - constructs: pfna, 1 unk - constructs: lfn, 7 unk - nails: femoral (1st pc).(b)(4) ¿ this complaint will include 7 devices ¿ 7 unk - nails: femoral (2nd pc).This report is for one (1) unk - constructs: pfna.This report is 2 of 10 for (b)(4).
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