MAUDE Adverse Event Report: SYNTHES GMBH LOCKING CALCANEAL PLATE SHORT-LEFT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, MULTIPLE COMPONENT, METAL COMPOSITE

Catalog Number	241.623
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.H3, h4: 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
Patient# (b)(6).Diabetes mellitus: no.Index surgery or revision surgery? index.Did a post-operative complication occur? yes.Describe post-operative complication(s): non-union.Comments/notes: non-union secondary to fracture pattern/comminution and bone loss.Union at (b)(6) weeks with new fixation.This report is for a locking calcaneal plate short-left.This is report 1 of 10 for pc (b)(4).
Event or Problem Description
It was reported that the patient was treated for a left severely comminuted fracture on an unknown date using a locking calcaneal plate.Eleven screws were used for fixation, and cancellous bone chips were used for adjunctive fixation.The patient experienced nonunion at 24 weeks postoperatively, and underwent a removal surgery to perform bone grafting and secondary fixation.Union was achieved at 36 weeks with the new fixation.This report is related to (b)(4), which captures two additional screws.

• Brand Name: LOCKING CALCANEAL PLATE SHORT-LEFT
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, MULTIPLE COMPONENT, METAL COMPOSITE
• 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: 17458989
• Report Number: 8030965-2023-09824
• Device Sequence Number: 7225548
• Product Code: LXT
• UDI-Device Identifier: 10886982167408
• UDI-Public: (01)10886982167408
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K991407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 241.623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: LOCKING CALCANEAL PLATE SHORT-LEFT; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male