MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP CLAVIC PL 2.7 LAT CS1 R TAN; PLATE, FIXATION, BONE

Catalog Number	04.112.611S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
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.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
Device report from synthes reports an event in japan as follows: this (b)(4) is related to (b)(4) which reports about the event which occurred in the removal surgery.This (b)(4) reports about the screw breakage which occurred after the first surgery.It was reported that on (b)(6) 2022, the patient underwent the osteosynthesis surgery for clavicle shaft fracture with the screw in question.The surgery was completed successfully without any surgical delay.After the surgery, nail extraction surgery was performed as bone fusion was achieved on (b)(6) 2023.In the removal surgery, it was found that one of the nine screws that fixed the clavicle plate (va-lcp clavicle plate 2.7/04-112-611s) had been broken completely on screw head since unknown date, while the other one screw had not been completely broken but been almost broken.The plate was removed and the screws including the two broken screw was also removed.2 of the 4 screw was broken, but two broken screws were used around the distal clavicle.The surgery was completed successfully within 30minutes surgical delay.Implant date:(b)(6) 2022.Explant date:(b)(6) 2023.Patient status/ outcome? stable.No further information is available.This report is for one (1) va-lcp clavic pl 2.7 lat cs1 r tan.This is report 1 of 3 for complaint (b)(4).

• Brand Name: VA-LCP CLAVIC PL 2.7 LAT CS1 R TAN
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16589858
• Report Number: 8030965-2023-03527
• Device Sequence Number: 14783887
• Product Code: HRS
• UDI-Device Identifier: 07612334214317
• UDI-Public: (01)07612334214317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 04.112.611S
• 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: 03/05/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 03/23/2023
• 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: CORTSCR ø2.7 SELF-TAP L16 TAN; LWPROF METAPHYS COMPRES SCR ø2.7 SELF-TA; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L12 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN; VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown