MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; WIRE,SURGICAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for unknown k-wire.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown k-wire.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: brunner a, weller k, et al (2010).Closed reduction and minimally invasive percutaneous fixation of proximal humerus fractures using the humerusblock.Journal of orthopedic trauma.Volume 24.Page 407-413.(switzerland).The purpose of this study was to evaluate the results after closed reduction and percutaneous fixation of displaced two-, three-, and four-part fractures of the proximal humerus using the humerusblock system and to compare the results with data presented in the literature.Between january 2002 and 2004, 58 patients (37 female and 21 male), with displaced fractures of the proximal humerus treated by closed reduction and percutaneous fixation using the unknown synthes humerusblock system, were included in the study.Additional unknown cannulated 4.0 mm cancellous screws were used to fix fragments of the greater tuberosity in 19 fractures.The mean age of patients at the time of the operation was 70.5 (range: 32¿95) years.Patients were followed up after 3, 6, and 12 weeks and 1 year postoperatively.The final clinical assessment was performed after a mean of 15.2 (range: 12¿28) months.7 patients had died because of causes unrelated to the fracture while 6 patients were unable to participate in the follow-up.Radiologic follow-up included anterior-posterior and transcapsular y-view x-rays and measurement of the radiologic head-to-shaft angle in the anterior-posterior view.Clinical assessment follow-up included range of motion, pain according to a visual analogue scale (vas) from 0 to 10, the constant- murley shoulder score13 of the operated and the nonoperated shoulder, and examination and documentation of the sensory and motor function of the axillary nerve.Complications were reported as follows: 15 patients had fractures with a minor valgus positioning of the head.1 patient had a fracture showing minor varus positioning on the postoperative anterior-posterior radiographs.13 patients had secondary impaction of the humerus head lead to perforation of the k-wires through the articular surface requiring early removal of the entire implant after an average time of 4.9 (range: 3¿6) weeks.5 patients required reduction and internal fixation with angular stable plates (unknown synthes proximal humeral internal locking system) because of early secondary fracture dislocation.A total of 23 patients required unplanned or premature surgical intervention.2 patients had shown radiologic signs partial avascular necrosis.4 patients were quite satisfied with the operative result, 1 patient was unsatisfied.A (b)(6) year-old- female patient had shown radiologic signs of a pseudoarthrosis.She achieved a constant-murley score of 19 points in the affected shoulder.The patient suffered from severe parkinson¿s disease, chronic alcoholic disease, diabetes, and severe coronary heart disease.Because of her subjective contentment and severe concomitant diseases, no further surgical intervention was performed.A (b)(6) year-old female patient had a postoperative reduction that did not achieve anatomic alignment and the lateral periostal bridging may have been insufficient to help to hold reduction.After 3 weeks, secondary fracture displacement occurred requiring open reduction and fixation with angular stable unknown synthes philos.13 patients had secondary impaction of the humerus head lead to perforation of the k-wires through the articular surface requiring early removal of the entire implant after an average time of 4.9 (range: 3¿6) weeks.A (b)(6) year-old female patient had unknown k-wires perforated into glenohumeral joint because of secondary impaction of the fragment, so early removal of k-wires was performed.One year postoperatively patient achieved constant-murley score of 71 points.This complaint (b)(4) captures eight (8) impacted products.(b)(4) captures linked three (3) impacted products.This report is for unknown k-wires.It captures the reported (b)(6) year-old female patient who had unknown k-wires perforated into glenohumeral joint because of secondary impaction of the fragment.This is report 3 of 8 for (b)(4).

• Type of Device: WIRE,SURGICAL
• 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: 8351126
• MDR Text Key: 136522995
• Report Number: 8030965-2019-61133
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• 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: 01/30/2019
• 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: 76 YR