MAUDE Adverse Event Report: SYNTHES GMBH EXPERT TIBIAL NAIL PROTECT Ø12 CANN L360; NAIL, FIXATION, BONE

Catalog Number 04.004.652SAB

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Non-union Bone Fracture (2369); Physical Asymmetry (4573); Insufficient Information (4580)

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.H10 additional narrative: a1: patient born on an unknown date in 1972.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: incident occurred in the netherlands, however, initial reporter is located in switzerland.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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 the netherlands reports an event as follows: the site (b)(6), netherlands) reported an adverse event in the ao database which is considered (possibly) related to the device.Subject: (b)(4).Ae1: postoperative adverse event: "other ae related to the procedure or implant ¿ rotational deviation (45 degrees) of the tibia" is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes" is the ae related to the device? "possible" dps implant was used.Patient was treated with external fixation on (b)(6) 2023 for open fracture of the left tibia and fibula.Tibial nail was implanted on (b)(6) 2023.Revision surgery occurred on (b)(6) 2023, to de-rotate the tibia.This report is for a expert tibial nail protect ø12 cann l360.This is report 1 of 4 for (b)(4).

Event Description

Additional adverse event reported: postoperative adverse event: "nonunion".Is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes".Is the ae related to the device? "possible".Dps implant was used.

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.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.

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.H11 additional narrative: corrected data: b5: event description updated.H6: health effect codes and medical device problem codes updated.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

This complaint was reviewed, and it was determined that the nonuinon reported was a separate event, which was captured in (b)(4).This report captures the first adverse event of physical asymmetry: ae1: postoperative adverse event: "other ae related to the procedure or implant ¿ rotational deviation (45 degrees) of the tibia".Is the ae related to the tibial fracture and/or treatment of tibial fracture? "yes".Is the ae related to the device? "possible".Dps implant was used.Patient was treated with external fixation on (b)(6) 2023 for open fracture of the left tibia and fibula.Tibial nail was implanted on (b)(6) 2023.Revision surgery occurred on (b)(6) 2023, to de-rotate the the tibia.

• Brand Name: EXPERT TIBIAL NAIL PROTECT Ø12 CANN L360
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18086183
• MDR Text Key: 327589024
• Report Number: 8030965-2023-14044
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819195882
• UDI-Public: (01)07611819195882
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Device Catalogue Number: 04.004.652SAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 04/27/2024; 04/27/2024
• Supplement Dates FDA Received: 05/21/2024; 05/24/2024
• 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 - END CAPS; UNK - SCREWS: LOCKING: TRAUMA; UNK - SCREWS: LOCKING: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 90 KG