MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L14 TA; SCREW, FIXATION, BONE

Catalog Number	04.211.014S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
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.H10 additional narrative: 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 or Problem 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 3 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 2 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) 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 14mm.This is report 3 of 3 for complaint (b)(4).

• Brand Name: VA LOCKSCR ø2.7 HEAD 2.4 SELF-TAP L14 TA
• Common Device Name: SCREW, FIXATION, BONE
• 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: 17452638
• Report Number: 8030965-2023-09792
• Device Sequence Number: 12577850
• Product Code: HWC
• UDI-Device Identifier: 10886982118998
• UDI-Public: (01)10886982118998
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• 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: 04.211.014S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/03/2023
• 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: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown