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

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

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Unspecified Infection (1930); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown plate.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown plate.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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: doornberg, j.N.Et al (2007), surgical treatment of intra-articular fractures of the distal part of the humerus.Functional outcome after twelve to thirty years., the journal of bone and joint surgery, vol.89 (7), pages 1524-1532, doi: 10.2106/jbjs.F.00369 (netherlands).The aim of this study is to evaluate the functional and radiographic outcomes twelve years or more after open reduction and internal fixation of ao-type-c intra-articular fractures of the distal part of the humerus and to identify predictors of diminished elbow function.Between 1974 to 2002, a total of 30 patients (18 male and 12 female) with an average age of thirty-five years (range: 13 to 64 year), had an operative treatment of a complete articular fracture of the distal part of the humerus (type c) using ao principles and techniques of internal fixation.Surgery was performed using 3.5-mm dynamic compression plates, one-third tubular plates, or 3.5-mm pelvic reconstruction plates (synthes, zeist, the netherlands).The patients were evaluated according to the mayo elbow performance index (mepi), the broberg and morrey functional rating index (broberg-morrey index), and the american shoulder and elbow surgeons (ases) score.They also completed the disabilities of the arm, shoulder and hand (dash) questionnaire, which is an upper-extremity specific outcome questionnaire.The following complications were reported as follows: 26 patients had died prior to the time of long-term follow-up.An (b)(6) year-old woman who experience a hardware that was causing symptoms, was removed one year postoperatively.12 patients had one or more subsequent surgical procedures.7 of them had removal of prominent hardware, which was combined with a release of an elbow contracture in 2 patients.2 patients who underwent index surgery had wound infection.1 of them underwent a serial irrigation and debridement, implant removal, and treatment with intravenous antibiotics but had an excellent result with no pain eleven years after the last surgical procedure.The other patient was treated with oral antibiotics alone.1 patient had malunion of the distal part of the humerus and underwent a removal of implants.1 patient who underwent anterior subcutaneous ulnar nerve transposition had painful ulnar neuropathy.1 patient had a very stiff and painful arthritic elbow after a type-c1.2 open distal humeral fracture, and an elbow arthrodesis was performed at one year after the injury.29 patients, excluding the patient with an arthrodesis, had an average arc of elbow flexion and extension of 106° (range:10° to 140°), with flexion averaging 129° (range: 95° to 145°) and an average flexion contracture of 23° (range: 0° to 100°).The average arc of forearm rotation was 165° (range: 125° to 180°), with pronation averaging 77° (range: 40° to 90°) and supination averaging 88° (range: 70° to 90°).All elbows were stable at the time of final follow-up.The average mepi score for the twenty-nine patients who did not have an arthrodesis was 91 points (range: 55 to 100 points), and the average broberg and morrey score was 91 points (range: 68 to 100 points).The average ases score of all thirty patients was 96 points (range: 69 to 100 points), with an average patient satisfaction score of 8.8 points and an average ases pain score of 20 points (range: 5 to 25 points) out of 25 points.None of the patients used pain medication.The average dash score for the patients, including the one with the elbow arthrodesis (who had a score of 7 points), was 7 points (range: 0 to 66 points), which was identical to that recorded in the general population in the united states.24 patients had arthrosis according to the radiographic criteria of broberg and morrey.11 patients had slight joint-space narrowing with minimum osteophyte formation (grade 1), 11 patients had moderate joint-space narrowing (grade 2), and 2 patients had severe arthrosis (grade 3).1 patient who had a hardware failure and substantial functional impairment, underwent revision of the osteosynthesis; also underwent the third operation for contracture release.Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints.This (b)(4).This report is for an unknown one-third tubular plates.It captures the reported adverse events such as patients who had one or more subsequent surgical procedures, wound infection, malunion, painful ulnar neuropathy, stiff and painful arthritic elbow, arthrosis, hardware failure, substantial functional impairment, average arc of elbow flexion and extension of 106°, mepi score result, ases score result, dash score result.This is report 6 of 6 for (b)(4).

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8578897
• MDR Text Key: 144004327
• Report Number: 8030965-2019-63467
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• 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
• Date Manufacturer Received: 04/08/2019
• 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