MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

Device Problem Migration (4003)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

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.Additional narrative: 510k: this report is for an unknown/unk - elastic nails: titanium.Device available for evaluation: complainant device is not expected to be returned for manufacturer review/investigation.Initial reporter name and address: (b)(6).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 taiwan as follows: this report is being filed after the review of the following journal article: ma, h.H., et al.(2022), is double-crossed retrograde elastic stable intramedullary nailing an alternative method for the treatment of diaphyseal fractures in the adult humerus? journal of orthopaedics and traumatology, vol.23:40, pages 1-9 (taiwan).The aim of this study was to compare two techniques for the surgical treatment of diaphyseal fractures in the adult humerus: double-crossed retrograde elastic stable intramedullary nailing (dcr-esin) and limited-contact dynamic compression plate (lc-dcp).We included 122 patients with diaphyseal fractures of the humerus who had received dcr-esin or lc-dcp from january 2011 to january 2017.Plating management was performed in 63 patients, while dcr-esin was performed in 59 patients.A 4.5-mm lc-dcp was used for the plating group while a ten was used for the dcr-esin group.The following complications were reported as follows: dcr-esin group: 1 case had nail backout with skin impingement followed by removal of the nails under local anesthesia.Plating group: cases experienced radial nerve injuries or implant impingements.Two of the cases had temporary neuropraxia with recovery after postoperative month 2.The other case had implant impingement with forearm numbness and a positive tinel¿s sign over the posterior aspect of their distal humerus.Neurolysis and removal of the plate were performed after bony union and the symptoms subsided.2 cases had surgical site infections: one was treated with oral antibiotics and the other received local debridement.3 cases had loosening screws that required prolonged sling use, with union achieved in all cases at follow-up.3 patients had delayed union at a mean of 28.6 weeks.3 patients had nonunions and underwent subsequent autograft revision surgery, with all showing union after the revision surgery.This report is for an unknown synthes ten and a 4.5-mm lc-dcp.This is report 1 of 3 for complaint: (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16279193
• MDR Text Key: 308572079
• Report Number: 8030965-2023-01239
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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

• 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
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/01/2023
• 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