MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 3.5 MM LCP CLAVICLE PLATE/SCREWS; PLATE, FIXATION, BONE

Device Problem Migration (4003)

Patient Problems Non-union Bone Fracture (2369); Osteolysis (2377)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: yeo mhx et al.(2022), acromion osteolysis and fracture following hook plate fixation after acute acromioclavicular joint dislocation in an elderly patient: a case report, journal of orthopaedic reports 1 (2022) 100055, https://doi.Org/10.1016/j.Jorep.2022.100055, (singapore).This study reports a case of acromial fracture following hook plate fixation for acromioclavicular joint dislocation.The patient was a 76-year-old caucasian woman who had a painful disability due to displaced acromioclavicular joint dislocation (rockwood type iii) after a fall on her left shoulder.She underwent open reduction-internal fixation 2 weeks after injury using an unknown synthes clavicular hook plate (4-hole plate with a 12-mm hook depth).There was no soft tissue damage found during the procedure.Patient was instructed to perform pendulum exercise, limit shoulder range-of-motion (rom) and avoid carrying weights during the first month of surgery.At both 3 weeks¿ and 7 weeks¿ follow-up, the patient complained of pain in her acromioclavicular joint with restricted rom and limited strength, even though there was no history of new injury to her acromioclavicular joint.At 3 weeks¿ follow-up, anteroposterior (ap) and scapular shoulder radiograph images confirmed the presence of focal osteopenia and earl signs of osteolysis in her left acromial joint.At 7 weeks¿ follow-up shoulder radiograph images showed acromial fracture and osteolysis over the acromial undersurface, distal clavicle and acromioclavicular joint, and the hook cutting out of the acromion.The hook plate was removed, and the acromion was secured with ethibond (ethicon) sutures.During surgery the coracoclavicular ligaments had scarred and there was minimal superior subluxation of the acromioclavicular joint.Following removal of the hook plate, radiograph images showed significant displacement of the acromioclavicular joint together with the acromial fracture.Throughout subsequent post-operative follow-ups, there was persistent mild pain but no signs of surgical site complications.At 6 months¿ follow-up, the patient had mild pain, moderate stiffness, limited rom on the left shoulder (forward flexion 123 degrees, abduction 103 degrees) and reduced strength (7/10 lbs).On ct scan examination it was found that the bone was not healed and there was displacement of acromioclavicular joint.Patient declined further revision surgery and bone grafting.Conservative arm sling fixation was applied to the patient.By 9 months¿ follow-up, obvious nonunion acromial fracture and acromioclavicular joint displacement was noted on radiographic examination however, the patient had no complaints of pain and was coping well with activities of daily living.Rom and strength did not worsen.This report 1 of 1 for (b)(4).This report is for the unknown synthes clavicular hook plate construct (4-hole plate with a 12-mm hook depth).

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.This report is for an unknown constructs: 3.5 mm lcp clavicle plate/screws/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.

• Brand Name: UNK - CONSTRUCTS: 3.5 MM LCP CLAVICLE PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15240529
• MDR Text Key: 298048419
• Report Number: 8030965-2022-05823
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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: 07/20/2022
• 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
• Patient Sex: Female