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

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

Patient Problems Pain (1994); Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 construct: 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.Initial reporter is a synthese employee.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.

Event Description

This report is being filed after the review of the following journal article davis, b., shybut, t., coleman, m.And shah, a.(2021) risk factors for hardware removal following operative treatment of middle- and distal-third clavicular fractures, journal of shoulder and elbow surgery, vol.30 (xx) pages e103¿e113 (usa) the aim of this retrospective study is (1) evaluate the incidence of postoperative hwr after plate fixation of middle- and distal-third clavicular fractures, (2) identify risk factors for hwr, and (3) characterize indications for hwr surgery.Between year 2008 to 2018, a total of 103 patients, 87 patients underwent plate and screw fixation for a midshaft clavicular fracture, 16 patients underwent plate and screw fixation for a distal third clavicular fracture with a mean age of 37.8 years (range, 16-75 years), 79 patients were male patients.Implants used varied widely and appeared to vary over time.The most common mechanisms of injury were falls, motor vehicle collisions, and sports injuries.There were no open fractures.The anatomic plate location was superior in 75 patients and anteroinferior in 1 patient, whereas dual plating was used in 27 patients.The following complications were reported as follows: middle third clavicle fracture hardware removal: patient #2- a 21-year-old male experienced pain with straps (backpack) and with palpation due to football; depuy synthes distal clavicle plate and screws patient #3- a 56-year-old male had a bicycle accident; dual plating: depuy synthese 2.7-mm and 2.4-mm lcp patient #4- a 57-year-old female experienced plate prominence and local irritation and/or discomfort: hypersensitivity and periincisional numbness due to fall; depuy synthese 2.4-mm lcp patient #5- an 18-year-old male experienced local irritation and/or discomfort: pain over superior clavicle with range of motion due to snowboarding; dual plating: depuy synthes 2.4-mm and 2.4-mm lcp distal third clavicle fracture hardware removal: patient #6- a 39-year-old male had a plate prominence due to fall; depuy synthese locking plate retained patient #7- a 68-year-old male experienced plate prominence and local irritation and/or discomfort due to fall; depuy synthese distal clavicle plate and coracoid screw patient #8- a 55-year-old female had a coracoid screw failure and hardware prominence due to fall; coracoid screw (depuy synthese distal clavicle plate retained) patient #9- a 41-year-old female had a plate prominence and local irritation and/or discomfort due to fall; depuy synthese distal clavicle plate 12 patients who experienced complications after index procedure: n= 4 early hardware failure* n= 3 hypertrophic scar or keloid n= 2 minor wound dehiscence n= 2 other soft tissue* n= 1 refracture this report is for an unk - construct: plate/screws.A copy of the literature article is being submitted with this medwatch.This is report 6 of 11 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: 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: 16628733
• MDR Text Key: 312151284
• Report Number: 8030965-2023-03736
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: 03/09/2023
• 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): Other