MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: HUMERAL NAIL; NAIL, FIXATION, BONE

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

Patient Problems Adhesion(s) (1695); Inflammation (1932); Discomfort (2330); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for an unk - constructs: humeral nail/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) as follows: this report is being filed after the review of the following journal article: hagiwara, y.Et al (2020), effects of arthroscopic pancapsular release for proximal humeral fractures treated with intramedullary nailing: a retrospective study, jses international, vol.4 (3), pages 546-550 (japan).The aim of this study is to retrospectively evaluate arthroscopic pancapsular release in patients with proximal humeral fractures treated with intramedullary nailing.Between may 2015 to february 2018, a total of 12 patients (5 male and 7 female) with a mean age of 65.1 years (range, 51-80 years; sd, 9.5 years) were included in the study.Surgery was performed using multiloc [depuy synthes, warsaw, in, usa] in 3 patients and competitor devices in 9 patients.The mean follow-up time between the initial surgical procedure and the pan capsular release was 6 months (range, 3-14 months; sd, 3.13 months), and the mean follow-up time after the second surgical procedure was 30.6 months (range, 14-46 months; sd, 11.7 months).The following complications were reported: 12 patients, 5 male (5 shoulders) and 7 females (7 shoulders) patients, in whom shoulder stiffness was diagnosed after intramedullary nail osteosynthesis and underwent arthroscopic pancapsular release.In 11 patients, rotator interval (ri) thickening was observed intraoperatively.In 11 patients, rotator interval (ri) synovitis was observed intraoperatively.In 12 patients, coracohumeral ligament (chl) adhesion was observed intraoperatively.In 2 patients, abnormal long head of biceps tendon (lhb) was observed intraoperatively.One had a tear and the other had a fibrillation.In 12 patients, superior labrum anterior-posterior (slap) lesion was observed intraoperatively.In 10 patients, suprascapular adhesion was observed intraoperatively.In 12 patients, anterior inferior glenohumeral ligament (aighl) thickening was observed intraoperatively.In 4 patients, posterior inferior glenohumeral ligament (pighl) thickening was observed intraoperatively.In 11 patients, subacromial bursa (sab) adhesion was observed intraoperatively.2 patients had discomfort at final follow-up.In 1 case, an articular perforated screw near the subscapularis tendon was observed, and the screw was removed.This report is for an unknown synthes humeral nail constructs and unknown synthes screws.This report is for (1) unk - constructs: humeral nail.This report is 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: HUMERAL NAIL
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11464070
• MDR Text Key: 250226950
• Report Number: 8030965-2021-01866
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/11/2021
• 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