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

Device Problem Use of Device Problem (1670)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cannulated screw/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: park, j.And chung, w.Y.(2016), osteochondral allograft reconstruction of talar body fracture with a large bone defect, archives of orthopaedic and trauma surgery, vol.136 (issue 1), pages 35-40 (korea, south).This study presents a case report of an (b)(6)-year-old male patient who had dislocation of both the subtalar and talonavicular joints.Emergency surgery was performed by a closed reduction and fixed with a competitor¿s device, which were removed 6 weeks after.However, computed tomography (ct) revealed a large talar body defect involving the talar posterior process.After wound care and soft tissue healing, reconstruction of this large bone defect with fresh frozen bulk osteochondral allograft was planned for 6 weeks after the index surgery.Surgery was performed using a competitor's device and the medial malleolar osteotomy was secured with two partially threaded cancellous screws (synthes, paoli, pa, usa).Postoperative ct demonstrated a slight mismatch of articular congruency.Three months after the last surgery, the patient was able to walk and was pain-free during daily activities with a slight limitation of rom of the ankle (10 degrees of dorsiflexion and 20 degrees of plantarflexion).Six months after the last surgery, the patient had no resting pain; however, slight ankle pain occurred after about 1 h of walking [visual analog scale (vas):1.6].Rom was 10 degrees of dorsiflexion and 30 degrees of plantarflexion.The ankle¿hind foot scale of the american orthopaedic foot and ankle society (aofas) scores was 80.One year after the last surgery, the patient still had slight ankle pain after walking (vas 1.5).Rom was 15 degrees of dorsiflexion and 30 degrees of plantarflexion, and the aofas score was 88.Two years after the last surgery, the slight ankle pain after walking persisted (vas 1.6).Rom was 15 degrees of dorsiflexion and 30 degrees of plantarflexion, and the aofas score was 88.The radiographs taken 1 year after the last surgery revealed mild posttraumatic osteoarthritic changes, especially in the medial tibiotalar joint and the medial gutter.However, the radiographs taken 2 years after the last surgery indicated very little progression of the osteoarthritis.One screw encroaching into the fibular cortex was inadvertently longer during surgery.Screws used for medial malleolar osteotomy were removed, and ct and magnetic resonance imaging (mri) were also taken 2 years after the last surgery to evaluate the state of transplanted allograft.Ct showed no collapse of talar dome of allograft, and mri demonstrated just articular cartilage thinning and mild posttraumatic osteoarthritic changes in both tibiotalar and subtalar joints.This is report 1 of 2 for (b)(4).This report is for an unknown synthes cancellous screws.

• Brand Name: UNK - SCREWS: CANCELLOUS
• 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: 9256342
• MDR Text Key: 180565806
• Report Number: 8030965-2019-69815
• 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: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 10/14/2019
• 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: 18 YR