MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 60MM; SCREW, FIXATION, BONE

Catalog Number 04.211.060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Inflammation (1932)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in france as follows: it was reported that the patient underwent surgery for supra-intercondylar fracture of the right distal humerus on (b)(6) 2022 for implantation of a lateral lecestre plate and osteosynthesis by screwing in the distal part and by classing screwing in the proximal part.Assembly: 1 plate + 2 l56 screws and 1 l60 screw.Single suite released on (b)(6) 2022.On (b)(6) 2022, the patient was admitted to the emergency room for elbow pain without trauma.The scar was clean with no discharge.On september 2, 2022, at a postoperative consultation, the control x-ray showed a secondary displacement at the plate.On (b)(6) 2022, the plate and screws were removed, and new osteosynthesis was performed with a new 6-hole plate and 5 screws.On (b)(6) 2022, a surgical revision was performed for secondary hemostasis under general anesthesia.The patient was discharged on (b)(6) 2022.Then, there was a deterioration of the health condition.On (b)(6) 2022, the patient was admitted to the emergency department for elbow edema and scar sweating.Clinical and biological x-ray check-up indicated an inflammatory syndrome: ablation of one staple out of two, followed by local care without antibiotic therapy.On (b)(6) 2022, a post-op consult showed relatively successful progress with less swelling of the elbow.The clinical examination revealed a perforation in the upper part of the scar, a rather clear liquid flow.The patient was in good general condition, without fever.A total ablation of the sutures was performed, and suspension of elbow mobilization.On (b)(6) 2022, two fistulas with high crp were confirmed.X-ray suggesting osteitis.Rcp criogo on (b)(6) 2022: indication of osteosynthesis of both columns with cleaning associated with broad spectrum antibiotic therapy (linezolide+ piperacilin tazobactam).A procedure was performed on (b)(6) 2022 using two locked plates: one postero-lateral and one medial.Patient was still hospitalized on (b)(6) 2022 under antibiotic therapy.Removed and new surgery was performed.This report involves one 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 60mm.The complaints (b)(4) are linked.This is report 1 of 4 for (b)(4).

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.Date of event: only the event year is known.Additional device product codes: hrs.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.

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 60MM
• Type of Device: SCREW, 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: 15888273
• MDR Text Key: 304554872
• Report Number: 8030965-2022-10436
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• 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: VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L56 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L56 TA; VA-LCP DHP 2.7/3.5 LAT R MED 2HO L82 TAN
• Patient Outcome(s): Required Intervention