MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS2/ RIGHT/ STERILE.; PLATE, FIXATION, BONE

Catalog Number	04.112.623S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2022
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.Event date: only the event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter facility name: (b)(6) hospital.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: it was reported that on (b)(6) 2022, the patient underwent the surgery with the products in question for clavicle trunk fracture due to a motorcycle accident.At the end of (b)(6), the patient had severe pain while driving and continued to have pain afterwards, so he was examined.It was found by examination that four va 2.7mm locking screws on the distal side and one va 2.7mm locking screw on the proximal end, for a total of five screws, were broken.Also, the fracture area was pseudoradicular.On (b)(6) 2022, since the bone was not fused, the surgeon removed all four broken screws, performed an iliac bone graft, and fixed with the anterior clavicle plate.The surgery was completed successfully without any surgical delay.The doctor confirmed by x-ray that there were no remaining damaged screws in the body.Regarding the cause of the breakage, the surgeon commented that the locking screw may have broken because of its narrow diameter.No further information is available.This report involves one 2.7mm ti va lcp clavicle plate shaft/ cs2/ right/ sterile.This is report 6 of 6 for (b)(4).

• Brand Name: 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS2/ RIGHT/ STERILE.
• Common Device Name: PLATE, 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: 15673090
• Report Number: 8030965-2022-08940
• Device Sequence Number: 12367566
• Product Code: HRS
• UDI-Device Identifier: 07612334214485
• UDI-Public: 07612334214485
• 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: 2022
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.112.623S
• Device Lot Number: 495P580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/18/2022
• 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: VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA.; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L18 TA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 79 KG