MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7 TI VA-LCP 2-C DRP STD 6H HD/10H SHAFT/145MM/RT-STER; PLATE, FIXATION, BONE

Catalog Number	04.111.680S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
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.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Product code: 04.111.680s, lot: 701p364, manufacturing site: mezzovico, release to warehouse date: 31 march 2022, and expiration date: 01 march 2032.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.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 japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent open reduction internal fixation (orif) for fracture of the forearm.The surgeon ordered up to extra-long on the right and normal size on the left.During the surgery, an inquiry was made from the operating room regarding the extra-long plate.The plate did not show up in time because the procedure for the right radius had already been completed and the left radius was already being processed.The prepared right 10-hole plate was used for the left radius.Surgery was completed successfully with less than thirty minutes delay.There was no patient consequence.This report is for a 2.4/2.7 ti va-lcp 2-c drp std 6h hd/10h shaft/145mm/rt-ster.This is report 1 of 1 for (b)(4).

• Brand Name: 2.4/2.7 TI VA-LCP 2-C DRP STD 6H HD/10H SHAFT/145MM/RT-STER
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16375704
• Report Number: 8030965-2023-01851
• Device Sequence Number: 7390833
• Product Code: HRS
• UDI-Device Identifier: 07612334110817
• UDI-Public: (01)07612334110817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K163046
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.111.680S
• Device Lot Number: 701P364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown