MAUDE Adverse Event Report: SYNTHES GMBH 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.004.555SAB

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient height reported as (b)(6).Patient¿s date of birth is an unknown date in 1979.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

The site (b)(6) reported two adverse events in our database which is considered (possibly) related to the device.Subject mue-010.Postoperative adverse event: "soft tissue wound lower leg; the epigard and the dermotraction still secrete bloody." is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes." is the ae related to the device? "yes." dps implant was used.This report is for a 11mm ti cannulated tibial nail-ex/375mm-sterile.This is report 1 of 5 for (b)(4).Additional reports are captured under (b)(4).

Event Description

The initial complaint was reviewed and found not reportable.It was determined this report is a duplicate report.Event was captured on complaint (b)(4), medwatch report 8030965-2022-02111.

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14074369
• MDR Text Key: 289007109
• Report Number: 8030965-2022-02353
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819195745
• UDI-Public: (01)07611819195745
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.004.555SAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• 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
• Treatment: UNK - SCREWS: NAIL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 86 KG