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

Device Problem Difficult to Advance (2920)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Nerve Damage (1979); Loss of Range of Motion (2032); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Pma/510k: this report is for an unk - end caps: humeral nail lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: 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.

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: zhongpeng q., et al (2016) different treatments for two-part and three-part proximal humeral fractures by neer classification: follow up results analyzed using clinical economics, chinese journal of tissue engineering research (8): 1188 -1195 (china).This study aims to discuss which treatment plan has more advantages, compares the clinical efficacy and overall cost of different treatment methods for two-part and three-part humeral fractures of neer classification, and uses clinical economic methods to compare the treatment effects and costs of different plans.From january 2011 to december 2016, the medical records of 130 patients were collected according to the study requirements.The patients were divided into a conservative treatment group, minimally invasive surgery group, intramedullary nail group, and locking plate group according to treatment methods there were 40 patients in the conservative treatment group, among whom there were 22 males and 18 females with a mean age of (68.67 ± 4.34) years.There were 22 patients in the minimally invasive surgery group, among whom there were 12 males and 10 females with a mean age of (60.09 ± 3.57) years.There were 32 patients in the locking plate group, among whom there were 17 males and 15 females with a mean age of (61.41 ± 6.74) years.There were 36 patients in the intramedullary nail group, where an intramedullary nail from johnson & johnson medical (shanghai) was used, among whom there were 19 males and 17 females with a mean age of (61.41 ± 6.74) years.All patients were followed up for 12-48 months.The following complications were reported as follows: 2 non-union.1 humeral head necrosis, was associated with disruption of humeral blood supply.1 shoulder impingement complications, was considered to be related to the patient's intraoperative shoulder cuff injury, bulging tail cap of the intramedullary nail and other reasons.1 nerve injury, was considered to have injury during intraoperative shoulder joint reduction and excessive traction and temporary fixation with kirschner wire.After the diagnosis of nerve injury after surgery, the patients were given nutritional nerve drugs for symptomatic treatment.1 infection, considered to be caused by the long duration of surgery and the long exposure time of the surgical field.This report is for unknown synthes intramedullary nail.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNK - END CAPS: HUMERAL NAIL
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 14939816
• MDR Text Key: 295401110
• Report Number: 8030965-2022-04598
• Device Sequence Number: 1
• Product Code: JDS
• 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,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: 07/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• 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