MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE, FIXATION, NAIL

Device Problem Migration (4003)

Patient Problems Discomfort (2330); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown dhs/dcs construct/unknown lot.Part and lot number 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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: radford p.J., howell c.J., (1992) the a0 dynamic condylar screw for fractures of the femur,injury volume 23 (2),pages 89-93 (united kingdom).This study aims to assess the use of a0 dynamic condylar screw for fractures of the femur.From may 1987 to april 1989, 24 fractures of the proximal or distal femur in 24 patients were treated with dcs implant.For proximal femoral fractures, a total of 11 patients (5 males and 6 females) with an average age of 68 years, although eight were over 75 years and two under 25 years who had fractures of the proximal femur which were all either pertrochanteric fractures with subtrochanteric extension or subtrochanteric fractures were included in the study.Dcs fixation was applied.Follow-up of these patients has averaged 13 months.For distal femoral fractures, a total of 13 patients (7 males and 6 females) with an average age of 59 years, although seven were over 70 years and four under 25 years with supracondylar, condylar or mixed fractures were included in the study.Dcs fixation was applied.Follow-up of these patients has averaged 11 months.The following complications were reported: one patient result during assessment was failure.The failure was a patient aged (b)(6) years with an oblique subtrochanteric fracture who slipped and fell in the ward i 7 days postoperatively causing failure of the fixation.After revision, the wound and fixation became infected and she died 36 days postoperatively.Scrutiny of the pre-failure radiograph showed that the dcs screw originally inserted was too short, presumably contributing to the failure of fixation.(proximal femoral fractures) the failures were both due to failure of fixation of the implant.One patient aged (b)(6) years had a closed oblique extra-articular (type a1.2) fracture which was reduced anatomically and fixed despite marked osteoporosis which precluded bone grafting as no useful graft could be harvested from her iliac crest.She slipped and fell 10 days postoperatively producing further fracturing and failure of fixation.She was treated non-operatively in traction and died 29 days postoperatively.(distal femoral fracture) four more patients have died from unrelated causes.(proximal femoral fractures).Another patient has died from unrelated causes.(distal femoral fracture).Three patients had a fair result during assessment.In the fair group, one patient developed an infection requiring removal of the implant at 8 months.Postoperatively, although the fracture had united without evidence of osteomyelitis.(proximal femoral fractures).Other complications encountered in this group were one pulmonary embolus.(proximal femoral fractures).Five patients had a fair result during assessment.The reasons for downgrading to fair results were restriction of knee flexion, varuslvalgus deformity and pain.(distal femoral fracture).The two other fair results were in patients: aged (b)(6) years and (b)(6) years who were downgraded to this group because of pain and restriction of range of motion, one being the patient with a pathological fracture.(proximal femoral fractures).Three screw migration.One rather prominent implant producing clicking and discomfort under the fascia lata.(proximal femoral fractures).The other failure occurred in a (b)(6) year-old patient with a comminuted transverse extra-articular fracture (type a3.2).She slipped and fell on to the knee 12 days postoperatively causing failure of fixation.This was treated non-operatively and the fracture united; the implant was subsequently removed, and the patient ultimately regained independent mobility.(distal femoral fracture).Two screw migration.This report is for an unknown synthes dynamic condylar screw (dcs).This is report 7 of 9 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10264398
• MDR Text Key: 199309336
• Report Number: 8030965-2020-04827
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: 07/03/2020
• 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
• Patient Outcome(s): Required Intervention