MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 412.105S

Device Problem Device Slipped (1584)

Patient Problems Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)

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.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: reporter is a j&j employee.Product was not returned.Based on the information available, it has been determined, that no corrective and 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 depuy synthes reports, an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an osteosynthesis with a va-lcp volar rim drp (04.115.751s) for fracture of the left distal radius.In the surgery, the va-lcp dhp in question (04.117.508s) was also applied to the dorsal side for joint fixation.Approximately (b)(6) months after surgery, bone union was confirmed.And removal of the implants was scheduled.After that, infection of the dorsal side and loosening of the screw was observed at the time of x-rays taken approximately (b)(6) weeks ago.On (b)(6) a removal surgery was performed.The palmar va-lcp volar rim drp was successfully removed.And bone union was observed to be achieved without problems.Dorsal side was infected, and the locking screw was loosening.None of the plates and screws were difficult to remove, and all the plates and screws could be removed.Procedure was completed successfully without any surgical delay.No further information is available.This report is for one (1) 3.5mm ti locking scr slf-tpng with stardrive recess 18mm.This is report 2 of 3 for complaint pc (b)(4).

• Brand Name: 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 18MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17452647
• MDR Text Key: 320328949
• Report Number: 8030965-2023-09793
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819152021
• UDI-Public: (01)07611819152021
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 412.105S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• 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: LOCKING; VA-LCP DHP 2.7/3.5 MED LE 8HO L160 TAN; VA-LCP VOLAR RIM DIST-RAD-PL2.4 LE SHAFT
• Patient Outcome(s): Required Intervention