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

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

Patient Problems Arthritis (1723); Inflammation (1932); Non-union Bone Fracture (2369); Osteolysis (2377); Muscle/Tendon Damage (4532); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown constructs: clavicle hook plate/screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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 switzerland as follows: this report is being filed after the review of the following journal article: baunach d., eid k., ricks m., and borbas p.(2021), long-term clinical and radiological results after hook plate osteosynthesis of lateral clavicle fractures, journal of orthopaedic trauma, vol.35 (7), pages 378¿383 (switzerland).The aim of this retrospective case series was to assess both clinical and radiological long-term outcomes after hook plate osteosynthesis for neer type ii lateral clavicle fractures.Between 1998 and 2007, a total of 21 patients (18 male and 3 female; mean age, 29.5 ± 9.7 years) who underwent open reduction internal fixation (orif) with a hook plate (synthes, solothurn, switzerland) were included in the study.After 3 months, the implant was removed if bony fracture union was confirmed on x-rays.If not, patients were followed up every 6 weeks, and hook plate removal was delayed until union was obtained.Twenty patients were available for the first follow-up at an average of 7.4 years (±2.3) while 18 patients were available for the second follow-up at an average of 13.9 years (±2.2).The following complications were reported as follows: 1 patient had a delayed union, and bony union was seen after 7.5 months.However, that patient was abroad afterward, so that the metal removal had to be delayed and was therefore performed 18 months after hook plate fixation.2 cases of acromial osteolysis were noted at the time of metal removal.An unknown number of patients had an artifact seen on imaging.An unknown number of patients had postoperative changes seen on imaging.11 patients had mild and 5 had intermediate ac joint osteoarthritis on the operated side.9 patients had mild and 9 had intermediate capsular hypertrophy of the ac joint on the operated side.5 patients had fluid in the ac joint on the operated side.11 patients had subacromial osteophytes on the operated side.10 patients had subclavicular osteophytes on the operated side.1 patient had subacromial bursitis on the operated side.7 patients had bone marrow edema of the lateral clavicle on the operated side.2 patients had positive tangent sign of the supraspinatus muscle on the operated side.5 patients had a partial tear of supraspinatus tendon on the operated side located in the articular side (n=2), intratendinous (n=1), and bursal side (n=2).11 patients had fatty infiltration of the supraspinatus muscle on the operated side with some fatty streaks in 10 while fat/muscle-ratio of 50% in 1.This report is for an unknown synthes clavicle hook plate/screws constructs.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: CLAVICLE HOOK 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: 14790687
• MDR Text Key: 295056656
• Report Number: 8030965-2022-04291
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• 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: 06/01/2022
• 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