MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE; PLATE, FIXATION, BONE

Catalog Number	04.112.620S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H11 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation e3: reporter is a j&j sales representative.Investigation summary 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 h3, h4, h6: a device history record (dhr) device history lot part: 04.112.620s, lot no: 6463p27, release to warehouse date: 07 june 2023, expiry date: 01 june 2033, manufacturing site: werk selzach, supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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
It was reported that on may 15, 2024, the patient underwent the surgery for clavicle fracture with the va clavicle plate and the va 2.7 locking screw in question.During surgery, the surgeon was concerned about plate floatation, so he inserted a va 2.7 locking screw while holding it down and observed the screw breakage under the screw head.Nothing remains in the body have been reported.The details are unknown.No further information is available at this time this report is for one (1) 2.7mm ti va lcp clavicle plate shaft/ cs1/ left/ sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 2.7MM TI VA LCP CLAVICLE PLATE SHAFT/ CS1/ LEFT/ STERILE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19515595
• Report Number: 8030965-2024-07335
• Device Sequence Number: 3328137
• Product Code: HRS
• UDI-Device Identifier: 07612334214348
• UDI-Public: (01)07612334214348
• 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: 2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.112.620S
• Device Lot Number: 6463P27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• 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 - PLATES: CLAVICLE.
• Patient Sex: Unknown