MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: CANNULATED; PLATE,FIXATION,BONE

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved in the study.Implantation date unknown.This report is for an unk - screws: cannulated/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.(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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: yih-shiunn l., chien-rae h., wen-yun l., (2007) surgical treatment of non-displaced femoral neck fractures in the elderly, international orthopedics volume 31, pages 677¿682 (taiwan).Between 1997 and 2003, a total of 114 elderly underwent internal fixation with either mcs or a 3-hole dhs (screw-plate system) for nondisplaced and impacted femoral neck fractures.There were 94 patients who met the inclusion criteria.Ten patients could not be followed up.A total of 84 patients with an average age of 71.6 years were included in the study.The 84 patients were divided into two groups: the dhs group included 40 patients with an average age of 72.8 years and the mcs group included 44 patients with an average age of 70.6 years.6.5 mm treated with (ao) cannulated screws.The average period of follow-up was 33.5 months (range 13- 60 months) for the dhs group and 35.6 months (range 12-68 months) for the mcs group.The following complications were reported as follows: dhs group: 4 patients had inadequate screw positions in dhs group.3 of 40 patients had avascular necrosis (avn) changes in the femoral head (ficat stage ii) but all were still pain free at the final follow-up.(dhs group).Another patient had severe avn (ficat stage iii) associated with painful daily activity and underwent hemiarthroplasty.(dhs group).In total, only one dhs patient required change of implant.Mcs group: 10 patients had inadequate screw positions in mcs group.Two cases had an inadequate screw position.(mcs group).3 patients had implant failures due to early screw loosening with displaced fractured gap.In these cases, all had adequate screw positions initially.Hemiarthroplasty was performed on these patients.(mcs group).All but two mcs fractures healed within six months.2 patients had non-union and underwent arthroplasty.(mcs group).A further two patients showed mild avn changes (ficat stage ii) and were treated conservatively.(mcs group).Another two patients (4.5%) developed severe avn (ficat stage iii) and underwent hemiarthroplasty.(mcs group).One of the above-mentioned two patients was diabetic with chronic renal insufficiency (fig.2).In total, seven patients in the mcs group required change of implants at the last follow-up.Fig.2 a case of a (b)(6) year old female patient with chronic renal insufficiency had a non-displaced femoral neck fracture treated with three cannulated screws.Preoperative radiograph showed non-displaced femoral neck fracture.Radiograph at postoperatively 4 months showed severe avascular necrosis of femoral head.Ten patients who could not be followed up included : death (five cases): three out of 46 patients treated with dhs and two out of 48 patients treated with mcs died before the final follow-up (the causes of death were not directly related to their hip fractures.) this report is for an unknown synthes dynamic hip screw (dhs) and multiple cannulated screws (mcs).This is report 7 of 8 for (b)(4).

• Brand Name: UNK - SCREWS: CANNULATED
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester 19380 ; 6103142063
• MDR Report Key: 9918155
• MDR Text Key: 196447712
• Report Number: 8030965-2020-02595
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• 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: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention