MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: CORTICAL : TRAUMA; SCREW, FIXATION, BONE

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: lans, j.Et al.(2020), functional outcomes and complications of radial head fractures treated with screw fixation, the orthopaedic journal at harvard medical school, vol.21, pages 25-32 (usa).The objective of this study is to evaluate the functional and patient reported outcomes of complex radial head fractures treated by bouquet screw fixation.A retrospective analysis of a18 patients (8 males and 10 females with an average age of 48.0±16.4 years (range: 22-71)) with a complex radial head fracture treated with bouquet screw fixation from february 2008 to april 2016 underwent radial head fixation.In the presence of lateral collateral ligament injury, this was reattached to the lateral humeral epicondyle using a suture anchor (mini quickanchor, depuy synthes, west chester, pennsylvania, usa).Cortical positioning screws sized 1.5mm to 2.0mm ranging from 18 mm to 34 mm in length (depuy synthes, west chester, pennsylvania, usa) were used, and the number of screws was determined intraoperatively.Four patients had fixation of the ulna using a locking compression plate (lcp, depuy synthes, west chester, pennsylvania, usa) and one patient had an olecranon fracture treated with tension band wiring.The median radiographic follow-up of 42 weeks (range: 10-125).The following complications were reported as follows: case 4: the patient had heterotropic ossification.Case 8: the patient had implant irritation and had implant removal.Case 16: the patient had nonunion and underwent radial head resection because of an unstable nonunion.Case 18: the patient had implant irritation and had implant removal.Case 21: the patient had nonunion and underwent implant removal because the radial head was found to be a stable, fibrous union intraoperatively after implant removal.Case 22: the patient had nonunion with no pain or functional impairment.The article does not provide sufficient information to identify which patient with postoperative compliocations (listed below) were associated with the lcp.Nonunion.Implant irritation.Heterotropic ossification.This report is for an unk - screw: cortical: trauma.This is report 2 of 7 for (b)(4).

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 screw: cortical: trauma/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 - SCREWS: CORTICAL : TRAUMA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15805948
• MDR Text Key: 303737102
• Report Number: 2939274-2022-03437
• Device Sequence Number: 1
• Product Code: HWC
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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: 10/25/2022
• 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): Other