MAUDE Adverse Event Report: SYNTHES GMBH 10MM TI CANNULATED TIBIAL NAIL-EX/390MM-STERILE; NAIL, FIXATION, BONE

Catalog Number	04.004.458SAB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Type of Reportable Event	Serious Injury
Additional 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.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.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 or Problem Description
Subject id: (b)(6).It was reported that the patient underwent a subsequent revision surgery on (b)(6) 2021 due to secondary loss of reduction.The original implant date was from the previous revision on (b)(6) 2021.Patient had previously experienced non-union from the initial surgery conducted on (b)(6) 2020.Hardware; tibial nail, 1 proximal dynamic interlocking screw, 3 distal static interlocking screws were removed.Irrigation and installation of a redon drainage was completed.This report is for one expert tibial nail protect ø10 cann l390 for (b)(4) (b)(4) is linked to (b)(4).(b)(4) is for the initial revision due to non union.(b)(4) is for the second revision due to loss of reduction.

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/390MM-STERILE
• Common Device Name: 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: 19322958
• Report Number: 8030965-2024-06275
• Device Sequence Number: 6335957
• Product Code: JDS
• UDI-Device Identifier: 10886982084279
• UDI-Public: (01)10886982084279
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.004.458SAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXPERT TIBIAL NAIL PROTECT Ø10 CANN L390; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown