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

Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.

Event Description

This report is being filed after the review of the following journal article: lee bs, et al.(2019), hinge fractures are underestimated on plain radiographs after open wedge proximal tibial osteotomy evaluation by computed tomography, the american journal of sports medicine, volume 47 (6), page 1370-1375, (south korea).The current study aimed to investigate the extent to which lateral hinge fractures are not identified by plain radiographs based on the actual incidence of lateral hinge fractures observed on computed tomography scans.In addition, the study aimed to assess whether lateral hinge fracture was associated with poorer clinical outcomes after medial open wedge high tibial osteotomy using a locking screw fixator.Between october 2013 and april 2016, 51 knees in 50 patients who had undergone medial open wedge high tibial osteotomy with locking plate fixation were included in the study.There were 36 women and 14 men with a mean age of 51.8 years (range, 24-64 years).All knees were fixated using an unknown synthes tomofix plate using an unknown synthes locking screw after grafting an allogenous bone chip into the osteotomy gap.Weightbearing was gradually introduced, from toe-touch during the first 2 weeks to full weight-bearing at 6 to 8 weeks postoperatively.Complications were reported as follows: 4 patients had type 1 lateral hinge fracture detected during intraoperative fluoroscopy.1 patient had type 2 lateral hinge fracture detected during intraoperative fluoroscopy.2 patients had type 1 lateral hinge fracture detected during immediate postoperative radiographs.5 patients had type 1 lateral hinge fracture detected during the 2-day computed tomography scans.These were not detected during the immediate postoperative radiographs.2 patients had type delayed lateral hinge fractures.A (b)(6) year old female patient had type 1 lateral hinge fracture detected during the 2-day computed tomography scan.This was not detected during the immediate postoperative radiographs.Callus formation was seen at 2 months on follow-up radiograph.A (b)(6) year old female patient had type 2 lateral hinge fracture detected during the 2-day computed tomography scans.This was not detected during the immediate postoperative radiographs.The double type 2 fracture became apparent on radiographs obtained 1 month after surgery.A (b)(6) year old female patient had type 3 lateral hinge fracture detected during the 2-day computed tomography scans.This was not detected during the immediate postoperative radiographs.The fracture line seen on the computed tomography scan became obvious with minimal displacement with bone resorption.This report is for the unknown synthes locking screws.It captures the reported events of a (b)(6) year old female patient who had type 3 lateral hinge fracture detected during the 2-day ct scan.This is report 8 of 8 for (b)(4).

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW, 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, PA 19380 ; 6103142063
• MDR Report Key: 10556806
• MDR Text Key: 209235855
• Report Number: 8030965-2020-07230
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/18/2020
• 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
• Patient Age: 58 YR