MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 2H/RT/85MM-MED-STER; PLATE, FIXATION, BONE

Catalog Number 04.117.602S

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

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.Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Product code: 04.117.602s.Lot: 725p451.Manufacturing site: mezzovico.Release to warehouse date: 04 april 2022.Expiration date: 01 march 2032.A manufacturing record evaluation was performed for the sterile 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 Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent open reduction internal fixation (orif) surgery for suprafoveal fracture of the left humerus.On (b)(6) 2022, the surgeon mistakenly ordered implants for the right.The mistake was discovered on the day of surgery, but the implants were used as-is after confirming whether it would fit the affected area.The surgery was completed successfully with no delay.Patient was stable.This report is for a 2.7mm/3.5mm ti va-lcp ext medl dhp 2h/rt/85mm-med-ster.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM TI VA-LCP EXT MEDL DHP 2H/RT/85MM-MED-STER
• Type of Device: 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: 15305879
• MDR Text Key: 305506806
• Report Number: 8030965-2022-06062
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819505643
• UDI-Public: (01)07611819505643
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 04.117.602S
• Device Lot Number: 725P451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VA-LCP DHP 2.7/3.5 LAT R SHORT 1-HO L69.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 45 KG