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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Loss of Range of Motion (2032); No Code Available (3191)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate.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.(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.

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: erhart s., et al (2017) restoring independency with an osteochondral graft of the navicular for coronoid process reconstruction, archives orthopaedic, and trauma surgery, volume 137, pages 225¿232, (austria).This study presents a case report of a patient to describe how arthrolysis and a meticulously planned surgery restored the independent activities of daily living in a polytraumatized patient.A case of a (b)(6) year-old male patient who was in a critical condition after a motorcycle accident.Ct scan showed serial rib fractures with severe haematopneumothorax.Furthermore, a right femoral shaft fracture and cmc iv and v locations, as well as a first-grade, open, complex, upper-extremity injury on the left, were detected.Due to hemodynamic instability, damage control surgery with external fixation of the femoral fracture and the open chain injury of the left upper extremity was performed.After 8 days, the femur was treated with intramedullary nailing.Definitive treatment of the left upper extremity was performed 19 days after injury with the following devices: elbow luxation with bony avulsion of the annular ligament medial coronoid process fracture disruption of the ulnar collateral ligament with screw fixation (2.7 and 2.3 mm), hinged fixator, radial fracture orif¿7-hole locking compression plate (lcp) distal ulna and ulna distal ulna and ulna shaft fracture orif¿8-hole lcp, wedge fixation (2 × 2.0 mm screws) orif¿plating with distal ulna plate.Due to pin irritation caused by the ulna plate, a revision of the hinged fixator had to be performed.In subsequent x-rays, a subluxation of the radial head was noticed.Hence, another revision surgery with debridement of pannus had to be performed.As there was not enough bony substance to reconstruct the sublime tubercle of the coronoid, a corticocancellous graft from the iliac crest was used for subchondral support.Under supervision, active motion exercises guided by the hinged fixator could be performed with a passive range of motion of s 0¿30¿85.Due to initial cognitive impairment, motion exercises were difficult to achieve by the patient himself and gained motion was lost concomitantly.The hinged fixator was removed after 4 weeks and the upper left extremity splinted for 2 more weeks.After 5 months, the patient presented with massive calcification at the elbow and heterotopic ossifications (hpo) between radius and ulna.The iliac crest graft showed a loss of substance at the articular surface.The main concern of the patient was reduced elbow motion and forearm rotation as neither wheelchair propelling nor wheelchair transfer was possible on his own.Eight months after trauma, the revision surgery was performed.After arthrolysis and hpo resection, the elbow showed a passive range of motion of s 0¿10¿120.However, radial and ulnar ligaments had to be resected leaving the elbow unstable.Subsequent reconstruction of the elbow joint was then achieved with an osteocartilaginous graft from the navicular to reconstruct the coronoid.Fixation of the graft at the elbow was achieved by a 2.4- mm l-shaped plate (depuy-synthes).Afterward, passive forearm rotation was r 80¿0¿60.The reconstruction was again protected by a hinged fixator.5 days postoperative intensive motion exercises were started.Analgesia was achieved with an infraclavicular plexus catheter.Before the patient was transferred to the rehab facility, elbow motion was s 0¿35¿110.Forearm rotation was r 20¿0¿80.The hinged fixator was removed after 5 weeks.One year after trauma, the patient was mobilized with a normal wheelchair.Elbow motion and forearm rotation were s 0¿40¿100 and r 10¿0¿80, respectively.The patient is able to move his left hand to his mouth, head, and neck.At follow-up at 2 years after the trauma, the patient is subjectively satisfied.He reports no pain at rest or during motion of the elbow.Wheelchair propelling and eating is possible without problems.The active range of motion in the elbow is s 0¿50¿130 and forearm rotation is r 0¿0¿80.The patient is not limited by the hypaesthesia in the region of the ulnar nerve.In follow-up x-rays as well as ct scans of the elbow, the joint is centred and fractures, as well as the graft, are fully healed.This report is for an unknown synthes 7 hole locking compression plate (lcp) , unknown synthes 8-hole locking compression plate (lcp) wedge fixation (2 × 2.0 mm screws) and unknown synthes for 2.4- mm l-shaped plate.This complaint involves six (6) devices.This is 1 of 6 for report (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: code 3191 used to capture loss of anatomical alignment after fracture reduction.H6: code 3191 used to capture nerve injury, not nerve damaged.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.

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9653367
• MDR Text Key: 190154013
• Report Number: 8030965-2020-00754
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR