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

Device Problems Break (1069); Device Slipped (1584)

Patient Problems Loss of Range of Motion (2032); Deformity/ Disfigurement (2360); Joint Dislocation (2374)

Event Date 09/01/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: wang, h.Et al (2022), predictive indicators for complications of proximal humerus fractures treated with locking plate or intramedullary nail fixation.Orthopaedic surgery., vol.14 (9) pages 2109-2118., (china).The aim of this retrospective cohort study was to evaluate the best placement of calcar screws in proximal humerus fracture surgeries.Between january 2017 and june 2020, a total of 98 patients (24 males and 74 females with mean age of 62.5 years) were included in this study.Included were 16 years old or older; a proximal humerus fracture with clinical and radiography evidence; receiving locking plates (philos, synthes, paoli, pa, usa) or intramedullary nails (the multi-loc nails, depuy synthes, raynham, ma, usa) internal fixation; followed up for at least 12-month postoperatively.The mean follow-up period was unknown.The article does not provide sufficient information to identify which synthes device associated with the adverse event as follows: failure of internal fixation (screw loosing and internal fixation breakage) was found in 5 of 98 patients in these two groups, which were treated with internal fixation removal (five of five) or replacement (two of five).4 of 5 patients with varus deformity preferred a conservative treatment and showed a satisfied result and the remaining one underwent an internal fixation removal which restricted his injured limb motion extremely at 8 months postoperatively.1 patient, a 73 years old female suffered from a proximal humerus fracture with a medial region disruption and anterior dislocation of shoulder received a locking plate fixation.It was found that the humerus stem and head had poor concord at 3 months postoperatively.This report is for an unk - nail: multiloc humeral.This is report 3 of 5 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 nail: multiloc humeral/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 - NAILS: MULTILOC HUMERAL
• Type of Device: NAIL, 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: 16216119
• MDR Text Key: 307811496
• Report Number: 8030965-2023-00702
• 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,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: 01/20/2023
• 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: 12/28/2022
• 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