MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: PHILOS; PLATE, FIXATION, BONE

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

Patient Problems Necrosis (1971); Nerve Damage (1979); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/27/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: wang j.Q., zhao y.M., jiang b.J., and ke c.R.(2021), a nomogram for predicting reduction loss risk after locking plate fixation for proximal humeral fractures, injury, vol.52 (xx), pages 2947¿2951 (china).The purpose of this retrospective study was to determine the risk factors for reduction loss in patients with proximal humeral fractures after locking plate fixation and establish a nomogram prediction model.Between january 2016 to december 2018, a total of 115 patients (52 male and 63 female) were included in the study.All patients underwent standard open reduction and philos plate (synthes inc., stratec medical ltd., solothurn, switzerland) internal fixation in the same medical group and received a standard postoperative rehabilitation training.The mean follow-up period was unknown.The following complications were reported as follows: 11 patients (4 male and 7 female; mean age of 72.82 ± 6.18 years) had reduction loss (the height loss of the humeral head from the plate more than 5 mm).Among them, 1 patient had screw cutting out which was removed by reoperation.3 patients had superficial wound infection, which healed after local dressing change and antibiotic injection.5 patients had delayed union (means four months after the operation, there was still a pain in the shoulder, and the x-ray showed that the fracture line was not blurred and the callus growth was rare), and all patients¿ fractures healed eventually.3 patients had subacromial impingement syndrome.We consider that these symptoms were caused by the plate, and the patient¿s symptoms improved after removal of the internal fixation.1 patient had humeral head necrosis and received shoulder hemiarthroplasty.This report is for unk - plates: philos.This is report 2 of 2 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 device/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 - PLATES: PHILOS
• 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: 15120973
• MDR Text Key: 296763496
• Report Number: 8030965-2022-05324
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 06/29/2022
• 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