MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7 VA 2C DRP NW 6HHD/7H SFT/105/L-S; PLATE, FIXATION, BONE

Model Number 02.111.571S

Device Problem Use of Device Problem (1670)

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

Event Date 08/29/2022

Event Type  malfunction  

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.Complainant part is not expected to be returned for manufacturer review/investigation.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.Device history lot
=
> part # 02.111.571s-us.Lot # l521289.Manufacturing site: (b)(4).Release to warehouse date: 25 aug2017.

Event Description

It was reported that on (b)(6) 2022, the surgeon reported that the plate did not fit the patient¿s anatomy.Additionally, the surgeon chose to cross the physis with the distal locking screws considering the fracture extended into the physis.There was no surgical delay and procedure was completed successfully.No fragments were generated.There was no patient outcome.This report is for one (1) 2.4/2.7 va 2c drp nw 6hhd/7h sft/105/l-s.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.4/2.7 VA 2C DRP NW 6HHD/7H SFT/105/L-S
• 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: 15454086
• MDR Text Key: 306267621
• Report Number: 8030965-2022-07089
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982031907
• UDI-Public: (01)10886982031907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.111.571S
• Device Catalogue Number: 02.111.571S
• Device Lot Number: L521289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 56 KG